MAUDE Adverse Event Report: 6CM X 10CM STRATTICE FIRM STOMA REINFORCED SHEET; MESH, SURGICAL

Catalog Number 0610008

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

Patient Problem Hernia (2240)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported re-herniation.Due to the legal process, if additional information is made available during legal proceedings the appropriate department will forward the information to product surveillance for further evaluation.The lot associated with this event was invalid and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, a relationship to the strattice was not determined.No further actions are required, a nonconformance was not confirmed.If additional information is received, a supplemental report will be submitted.

Event Description

It was reported through legal, that a (b)(6) year old male patient underwent hernia repair surgery on (b)(6) 2016 at (b)(6) medical center in (b)(6).The patient was implanted with strattice lot (b)(4).The patient returned to the hospital on (b)(6) 2018 and was diagnosed with a recurrent ventral hernia requiring revision surgery at (b)(6) medical center in (b)(6).(b)(4); however, the sublot is missing a digit; therefore the lot number is invalid.

Manufacturer Narrative

No other information was reported.Internal investigation into strattice lot sp100381 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 09/22/2022, of the (b)(4) devices released to finished goods for lot sp100381, 171 have been distributed with 74 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.As reported in the initial: this legal event is being reported as serious injury due to the reported re-herniation.Due to the legal process, if additional information is made available during legal proceedings the appropriate department will forward the information to product surveillance for further evaluation.The lot associated with this event was invalid and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, a relationship to the strattice was not determined.No further actions are required, a nonconformance was not confirmed.If additional information is received, a supplemental report will be submitted.

Event Description

This is follow up#1 to report on september 14th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and are sp100381-175 (9/22/2016 implant) and sp100607-052 (10/18/2018 implant)".No other information was reported.Sp100381-175 has been provided as the full valid lot number.There is no complaint against sp100607-052 since there was no reported complications after the (b)(6) 2018 implant date and no record will be opened.This record is associated with sp100381-175.As reported in the initial: it was reported through legal, that a 61 year old male patient underwent hernia repair surgery on (b)(6) 2016 at oakwood hospital and medical center in dearborn, michigan.The patient was implanted with strattice lot sp100381-75.The patient returned to the hospital on (b)(6) 2018 and was diagnosed with a recurrent ventral hernia requiring revision surgery at (b)(6) medical center in dearborn, michigan.Sp100381-75; however, the sublot is missing a digit ; therefore the lot number is invalid.

• Brand Name: 6CM X 10CM STRATTICE FIRM STOMA REINFORCED SHEET
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12569036
• MDR Text Key: 276920606
• Report Number: 1000306051-2021-03063
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010041
• UDI-Public: 00818410010041
• 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,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0610008
• Device Lot Number: SP100381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male