MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM; MESH, SURGICAL

Catalog Number	2540002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient underwent a hernia repair with strattice and was later diagnosed with an acute small bowel obstruction with incarcerated hernia requiring removal of the strattice mesh.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.
Event or Problem Description
It was reported that a (b)(6) year old male patient underwent a hernia repair on (b)(6) 2016 at (b)(6) in (b)(6) and was implanted with strattice lot sp100442-201.After the surgery, the patient returned to the hospital on (b)(6) 2019 and was diagnosed with an acute small bowel obstruction with incarcerated hernia requiring removal of the strattice mesh at (b)(6).
Event or Problem Description
As reported in the initial: it was reported that a 52 year old male patient underwent a hernia repair on (b)(6) 2016 at (b)(6) medical center in (b)(6) and was implanted with strattice lot sp100442-201.After the surgery, the patient returned to the hospital on (b)(6) 2019 and was diagnosed with an acute small bowel obstruction with incarcerated hernia requiring removal of the strattice mesh at (b)(6) medical center.
Additional Manufacturer Narrative
This is a follow up #1 report to the internal investigation and conclusion.The internal investigation into strattice lot sp100443 included a review of the reported information, review of the device history records and review of the complaint history records.The device was not returned to lifecell for evaluation.Investigation results revealed no remarkable findings including no other complaints reported against the lot and no related deviations or nonconformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, of the (b)(4) released to finished goods for lot sp100443, (b)(4) have been distributed.No further actions are required as a nonconformance could not be confirmed.
Additional Manufacturer Narrative
This is to report a correction to the aware date on the follow up# 1 report submitted on 7/20/2021.The aware date was documented as 6/10/2021, but the correct aware date was 7/15/2021.Aware date was changed due to the batch record completion date being 7/15/2021.As reported in follow up #1: this is a follow up #1 report to the internal investigation and conclusion.The internal investigation into strattice lot sp100443 included a review of the reported information, review of the device history records and review of the complaint history records.The device was not returned to lifecell for evaluation.Investigation results revealed no remarkable findings including no other complaints reported against the lot and no related deviations or nonconformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, of the (b)(4) devices released to finished goods for lot sp100443, 185 have been distributed.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
As reported in the initial & follow up#1: it was reported that a 52 year old male patient underwent a hernia repair on (b)(6), 2016 at metrowest medical center in framingham, ma and was implanted with strattice lot sp100442-201.After the surgery, the patient returned to the hospital on (b)(6), 2019 and was diagnosed with an acute small bowel obstruction with incarcerated hernia requiring removal of the strattice mesh at beth israel deaconess medical center.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 12124588
• Report Number: 1000306051-2021-03013
• Device Sequence Number: 17135230
• Product Code: FTM
• UDI-Device Identifier: 00818410010416
• UDI-Public: 00818410010416
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2021

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 Catalogue Number: 2540002
• Device Lot Number: SP100443
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 07/15/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/20/2021; 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION; NO INFORMATION; NO INFORMATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR