MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 20, FIRM; MESH, SURGICAL

Catalog Number 1020002

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

Patient Problem Hernia (2240)

Event Date 09/05/2012

Event Type  Injury  

Manufacturer Narrative

Internal investigation into strattice lot s10969 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 related deviations or non-conformances revealed during manufacturing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 1/24/22, all 167 devices released to finished goods have been distributed with 120 devices reported as implanted.

Event Description

It was reported through legal that a (b)(6) male patient underwent hernia repair surgery on or about (b)(6) 2012 at deaconess health system in (b)(6).The patient was implanted with lot s10969-105.After surgery, the patient returned to the hospital on or about (b)(6) 2012 and was diagnosed with a recurrent parastomal hernia.On or about (b)(6) , the patient underwent a parastomal herniorrhaphy with mesh at deaconess health system and was implanted with strattice lot s11047-107.The patient was (b)(6) at that time.The patient returned to the hospital on or about (b)(6) 2013 and was diagnosed with chronic abdominal pain with parastomal hernia.The patient had a repair of the parastomal hernia on or about (b)(6) 2013 at barnes-jewish hospital.This record is associated with device lot s10969-105.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 20, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13475549
• MDR Text Key: 288671909
• Report Number: 1000306051-2022-00007
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1020002
• Device Lot Number: S10969
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2022
• 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 REPORTED
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male