MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM; MESH, SURGICAL

Catalog Number 2020002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot s10605 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 08/23/2022, of the (b)(4) devices released to finished goods for lot s10605, (b)(4) have been distributed with 110 reported as implanted.Based on our internal investigation with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

On 8/2/22, pmqa received notification that the lot number associated with (b)(4) was found through discovery.At the same time of notification, it was also reported that an additional mesh was implanted, lot s10605-030 on (b)(6) 2010.This information was not reported in the original legal summons.Refer to mw 1000306051-2022-00021 for the additional associated event details.The patient returned to the hospital on or about (b)(6) 2018 for a mesh explant surgery and since it is unknown at this time what device was explanted on (b)(6) 2018, this record was opened to capture the event of assumed re-herniation with device explant for device lot s10605-030 since explant surgery took place after implantation.The original event reported: limited information was reported through a legal event that a 44 year old male patient underwent hernia repair surgery on or about (b)(6) 2009 and the surgeon implanted a strattice mesh in him.After surgery, the patient returned to the hospital on or about (b)(6) 2018 for a mesh explant surgery.This record is associated with lot s10605-030 implanted on (b)(6) 2010.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15311004
• MDR Text Key: 298787574
• Report Number: 1000306051-2022-00140
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2020002
• Device Lot Number: S10605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO INFORMATION
• Patient Outcome(s): Required Intervention