MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM; MESH, SURGICAL

Catalog Number	1010002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The internal investigation into strattice lot sp100353 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 with no similar complaints reported against the lot and no 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 sp100353, (b)(4) have been distributed.Of the (b)(4) distributed, (b)(4) have been reported as implanted.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
It was reported that the patient had hernia repair surgery on (b)(6) 2013, (b)(6) 2015, (b)(6) 2016, (b)(6) 2017, (b)(6) 2017, and (b)(6) 2018.The patient was a female between the ages of 38 and 43 at the times of surgery.The patient was implanted with strattice lot sp100353-152, implanted on (b)(6) 2016 (record 3 of 6).The patient returned to the hospital on (b)(6) 2018 and (b)(6) 2019.On (b)(6) 2018, the patient had lysis of adhesions and removal of the mesh and a hernia repair at (b)(6) medical center.On (b)(6) 2019 the patient had another surgery requiring additional removal of the strattice mesh at (b)(6) medical center.This record is for the device lot sp100353-152, implanted on (b)(6) 2016.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• Common Device Name: MESH, SURGICAL
• MDR Report Key: 12218181
• Report Number: 1000306051-2021-03036
• Device Sequence Number: 17150861
• Product Code: FTM
• UDI-Device Identifier: 00818410010096
• UDI-Public: 00818410010096
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 1010002
• Device Lot Number: SP100353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention