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 Abscess (1690); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Ref corresponding author and institution.This literature review is being reported as an individual event type as serious injury due to the medical intervention to treat the complications of abscess and infection.As per the article, none of the strattice devices had to be removed; therefore, no devices were returned for evaluation.Multiple attempts are being made to gather additional patient and procedure specific information including lot numbers.To date, the lot numbers associated with these events remain unknown; therefore, an internal investigation into the device history records could not be performed.A relationship to the strattice could not be determined.As per the ifu, potential adverse events are those typically associated with surgical mesh materials and/or their implantation procedures including, but not limited to, infection.If additional information is received, a follow up report will be submitted.No further actions are required as a nonconformance could not be confirmed.

Event Description

During a literature review, an article titled "simultaneous stoma reinforcement and perineal reconstruction with biological mesh - a multicentre prospective observational study" was identified which reported a non-comparative study of consecutive patients undergoing extralevator abdominoperineal excision (elape) for low rectal cancer and simultaneous perineal reconstruction and colostomy site reinforcement with strattice¿ mesh to assess prevention of hernia formation.A total of 19 patients (11 males, 8 females) were entered into the study.Results reported that 3 patients had a parastomal hernia detected radiologically, 1 patient had pre-sacral abscess requiring antibiotics, and 1 patient had wound infection requiring vacuum dressing.No mesh was removed during the 12 month follow up period.Conclusions reported that perineal and parastomal reconstruction with biological mesh is a feasible approach for parastomal and perineal hernia prevention after laparoscopic and open elape.

• 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: 8301265
• MDR Text Key: 134877731
• Report Number: 1000306051-2019-00022
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• 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: 67 YR