MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL; MESH, SURGICAL, POLYMERIC

Model Number UNK-PERMACOL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hernia (2240); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A.M.Warwick, r.Velineni, n.J.Smart, i.R.Daniels (2016).Onlay parastomal hernia repair with cross-linked porcine dermal collagen biologic mesh: long-term results, hernia, 20:321-325.Doi 10.1007/s10029-015-1452-8 purpose the optimal technique and mesh type for parastomal hernia repair have yet to be ascertained.Biologic meshes have been advocated in parastomal hernia repair due to purported resistance to infection in contaminated fields.The aim of this study was to evaluate the effectiveness of additionally cross-linked acellular porcine dermal collagen mesh (permacoltm) for onlay parastomal hernia repair.Methods a retrospective review of case notes, and abdominal ct scans when available, was performed for consecutive patients who had a parastomal hernia repaired between january 2007 and may 2010.Results over a 34-month period, 30 consecutive patients, median age 74 years, 17 female, underwent parastomal hernia repair using onlay biologic mesh.There were 23 paracolostomy and seven paraileostomy hernias.The hernia was primary in 26 patients.Approx 29 patients were available for follow-up, median duration of follow-up (either ct or clinical) was 36 months (range 3¿79).Approx 11 patients developed recurrence.

• Brand Name: PERMACOL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6595413
• MDR Text Key: 76129447
• Report Number: 9617613-2017-05084
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-PERMACOL
• Device Catalogue Number: UNK-PERMACOL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 05/26/2017
• 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): Other