MAUDE Adverse Event Report: ETHICON INC. SURGICEL NU-KNIT 6INX9IN(15.2CMX22.9CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	1946
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4): device not returned.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported by an attorney that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used.The absorbable hemostat was used to stop bleeding during the surgery.The absorbable hemostat was left in the body and closed, resulting in nerve damage.A substance thought to be the absorbable hemostat has been removed from the body and stored.It has been considered with the plaintiff, the defendants, and the court whether the removed substance is really the absorbable hemostat or not.Inquiries were made to several laboratories and facilities, however all of them have replied it is hard to make a determination.No further information will be provided.

• Brand Name: SURGICEL NU-KNIT 6INX9IN(15.2CMX22.9CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11661064
• Report Number: 2210968-2021-03316
• Device Sequence Number: 2936345
• Product Code: LMG
• UDI-Device Identifier: 10705031002999
• UDI-Public: 10705031002999
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1946
• Device Catalogue Number: 1946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention