MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

Catalog Number UNK STRATTICE

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Scarring (2061)

Event Type  Injury  

Manufacturer Narrative

This legal complaint is being reported in an abundance of caution due to the alleged serious injuries. Based on the reported information, it is unclear regarding the timeline of the adverse events for scarring, adhesions and other serious injuries including chronic abdominal pain and therefore cannot be confirmed if the strattice device was involved in the post-operative complications or if strattice caused or contributed to the events reported. The patient's alleged recurrent hernias occurred with another manufacturer's mesh product prior to the implantation of strattice. Due to the legal process, no follow up attempts can be performed for patient and procedure specific information, including the relevant strattice lot number, implant dates or patient's medical records. Without the associated lot number, an internal investigation cannot be performed. At this time, a relationship to strattice cannot be determined. If additional information is received through the legal process, a follow up report will be submitted. This report concludes our investigation.

Event Description

A legal complaint was received against strattice. The plaintiff alleges that they underwent a ventral hernia repair on (b)(6) 2010 with another manufacturer's hernia mesh product. Subsequently, they underwent multiple surgeries due to the mesh implant failure causing recurrent hernias, which resulted in them being implanted with a strattice matrix and another manufacturer's mesh product, as well as other adverse reactions including significant scarring and adhesions and other serious injuries including chronic abdominal pain. As a result of having the "hernia mesh products" implanted, the plaintiff alleges significant mental and physical pain and suffering and mental anguish, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 7601102
• MDR Text Key: 111052285
• Report Number: 1000306051-2018-00080
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2018
• 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 Treatment Data

Date Received: 06/14/2018 Patient Sequence Number: 1

Treatment

NO INFORMATION