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

Catalog Number 1010002

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

Patient Problem Hernia (2240)

Event Date 07/01/2013

Event Type  Injury  

Manufacturer Narrative

Internal investigation into strattice lot s11047 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 1/25/22, all (b)(4) devices released to finished goods have been distributed with (b)(4) devices reported as implanted.

Event Description

It was reported through legal that a (b)(6) year old male patient underwent hernia repair surgery on or about (b)(6) 2012 at (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 (b)(6) and was implanted with strattice lot s11047-107.The patient was (b)(6) years old 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 (b)(6).This record is associated with device lot s11047-107.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13475514
• MDR Text Key: 288671436
• Report Number: 1000306051-2022-00008
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1010002
• Device Lot Number: S11047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/07/2022
• 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: 63 YR
• Patient Sex: Male