MAUDE Adverse Event Report: STRATTICE LAPAROSCOPIC 10CM X 16CM; MESH, SURGICAL

Catalog Number	1016005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a (b)(6) female patient underwent a recurrent ventral hernia repair surgery on (b)(6) 2016 at (b)(6).During the surgery, the surgeon implanted two strattice meshs: lots sp100398-178 and sp100393-230.After surgery, the patient returned to the hospital on (b)(6) 2017 because of pain and swelling to her lateral abdomen.She had a partially reducible hernia containing small bowel and the serosa was intimately involved with the strattice.On (b)(6), 2017 the patient underwent a revision surgery performed by the same implanting physician.It should be noted that as per legal, the complaint lists sp100393-230 as one of the lot numbers, but they determined through discovery that the correct lot number is sp100529-283.This record is associated with lot sp100398-178.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100398 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 04/27/2022, of the 300 devices released to finished goods for lot sp100398, 282 have been reported as distribution with 152 reported as implanted.Based on our internal review with no remarkable findings, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.

• Brand Name: STRATTICE LAPAROSCOPIC 10CM X 16CM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14270128
• Report Number: 1000306051-2022-00067
• Device Sequence Number: 5703451
• Product Code: FTM
• UDI-Device Identifier: 00818410012823
• UDI-Public: 00818410012823
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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 Catalogue Number: 1016005
• Device Lot Number: SP100398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female