MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 8 X 16, PLIABLE; MESH, SURGICAL

Catalog Number 0816001

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

Patient Problem Hernia (2240)

Event Date 01/21/2014

Event Type  Injury  

Event Description

It was reported through a legal event that a 34 year old male patient had hernia repair surgery on or about (b)(6) 2013.During the hernia repair surgery, plaintiff¿s surgeon implanted a strattice mesh; catalog number for this mesh is 0816001 and the lot number is s11128-531.On or about (b)(6) 2014, the patient returned to the hospital reporting abdominal distention and pain.On or about (b)(6) 2014, the patient returned for a surgical repair of a recurrent incisional hernia.The patient underwent a component separation, adhesions were cut, and an additional strattice mesh was placed.The records indicate this is a lifecell strattice firm mesh; catalog number 3030002 and lot number is s11344-080.After surgery, the patient returned to the hospital on or about (b)(6) 2014, reporting abdominal pain and cellulitis.He was diagnosed with a left side abdominal wall abscess.An incision and debridement were performed and wound vac was placed.On or about (b)(6) 2014, the patient underwent exploration and drainage of abdominal wall abscess and removal of foreign body.He underwent wound vac placement on or about (b)(6) 2014.On or about (b)(6) 2016, the patient underwent surgical repair for a recurrent incisional hernia repair.Adhesions were cut and additional mesh was placed.This record is associated with lot s11128-531 implanted on (b)(6) 2013 with first date of occurrence as (b)(6) 2014 since it is the first date provided of any intervention.Record 1 of 2.

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot s11128 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 7/28/2022, of the 525 pieces released to finished goods for lot s11128, 270 have been distributed with 46 reported as implanted.Based on our internal review 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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 8 X 16, PLIABLE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15188424
• MDR Text Key: 297489110
• Report Number: 1000306051-2022-00133
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0816001
• Device Lot Number: S11128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male