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

Model Number P101828

Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Diarrhea (1811); Purulent Discharge (1812); Erythema (1840); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Rash (2033); Seroma (2069); Vomiting (2144); Chills (2191); Hernia (2240); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); Nodule (4551); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced ventral hernia recurrence, incarcerated hernia, mesh stretched out/splayed, mesh migration, folded mesh, adhesions, small bowel obstruction, fistula, infection, abscess, drainage, draining sinus tract, nausea, vomiting, abdominal pain, fluid collection, and purulent fluid. Post-operative patient treatment included mesh explant, multiple recurrent ventral hernia repairs with implant of new mesh, lysis of adhesions, admission to hospital, excision of draining sinus tract, tpn, evacuation of purulent fluid collection, and fistula repair.

• Brand Name: PERMACOL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• Manufacturer Contact: justin ellis ; 60 middletown ave.; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 11825287
• MDR Text Key: 250816429
• Report Number: 9617613-2021-00016
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000139
• UDI-Public: 10884523000139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/18/2010
• Device Model Number: P101828
• Device Catalogue Number: P101828
• Device Lot Number: 07B05-9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 05/14/2021 Patient Sequence Number: 1