Johnson & Johnson's Subsidiary Discontinues Some Megadyne Electrodes For Pediatric Use
Johnson & Johnson's Subsidiary Discontinues Some Megadyne Electrodes For Pediatric Use
Johnson & Johnson's (NYSE:JNJ) medical device subsidiary is pulling its Megadyne Mega Soft Pediatric Patient Return Electrodes following reports of patient burns.
在有患者燒傷報道後，強生（紐約證券交易所代碼：JNJ）醫療器械子公司正在撤出其Megadyne Mega Soft兒科患者回流電極。
Ethicon's Megadyne division recalled its Mega Soft and Mega 2000 return electrodes in June 2023. The soft reusable pads are used during electrosurgery.
Ethicon 的 Megadyne 部門於 2023 年 6 月召回了其 Mega Soft 和 Mega 2000 回流電極。可重複使用的軟墊用於電外科手術。
The electrode aims to minimize the risk of electrical burns by ensuring the current flows safely through the patient's body and back to the electrosurgical unit, preventing any concentration of electrical energy in one area of the body.
該電極旨在通過確保電流安全地流經患者身體並返回電外科設備，防止電能集中在身體的一個部位，從而最大限度地降低電燒傷的風險。
Previously labeled a Class I recall by the FDA, the agency's most serious category, the move impacted 21,200 devices distributed over two years.
此舉此前曾被美國食品藥品管理局列爲I類召回，這是該機構最嚴重的類別，此舉影響了兩年內分發的21,200臺設備。
The FDA has said it collected reports of at least 63 injuries, including some third-degree burns, and zero patient deaths.
美國食品藥品管理局表示，它收集了至少63人受傷的報告，包括一些三度燒傷，患者死亡人數爲零。
The recall was expanded in December 2023 to update certain devices' product labeling and restrict their use to patients 12 years and older, covering around 9,500 units.
2023年12月，召回範圍擴大到更新某些設備的產品標籤，並僅限12歲及以上的患者使用，涵蓋約9,500臺。
Because the pediatric pad is designed for patients between 0.8-50 pounds, predominantly patients under 12, the decision was made to discontinue and recall the 0840 pediatric pad product.
由於兒科衛生巾是爲體重在0.8-50磅之間的患者設計的，主要是12歲以下的患者，因此決定停產並召回0840兒童護墊產品。
"A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries," J&J's Megadyne said in its announcement.
強生的Megadyne在其公告中表示：“對報告的根本原因調查包括測試，該測試表明，多種因素共同存在可能導致熱損傷。”
"The combination of these conditions may be more likely when the pad is used with infants and small children," the company said.
該公司表示：“當嬰兒和小孩使用衛生巾時，這些情況結合的可能性更大。”
Between 2018 and today, there have been four reported injuries and no reports of death associated with this product."
從2018年到今天，已報告了四人受傷，沒有與該產品相關的死亡報告。”
Price Action: JNJ shares are up 0.41% at $150.62 at last check Monday.
價格走勢：週一最後一次檢查時，JNJ股價上漲0.41％，至150.62美元。
Photography Via Shutterstock
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譯文內容由第三人軟體翻譯。