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

Model Number UNKNOWN PERMACOL PRODUCT

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Cellulitis (1768); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. (b)(4). 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 hernia. It was reported that after the implant, the patient experienced recurrence, abscess, streptococcus anginosus, moderate prevotella buccae, moderate clostridium clostridiiforme, fluid and gas in abdominal wall, adhesions, fistula, cellulitis, urinary tract infection, infection, serosal injuries, mesh migration, wrinkled edges of mesh, abdominal pain, mesh not incorporated, purulent material, necrotic tissue, drainage of green fluid, swelling, nausea, popping sensation, sinus tract, mesh eroded into the small bowel, bile leaking through the skin, inflammation, and pain. Post-operative patient treatment included revision surgery, admission to hospital, lysis of adhesions, hernia repair, wrinkled edges of mesh cut away, debridement of abdominal wall, repair of serosal injuries, removal of 2 portions of infected abdominal wall mesh, placement of 2 subcutaneous drains, covering site with ostomy appliance, antibiotics, drainage of abscess, small bowel resection with handsewn anastomosis, removal of fistula, excision debridement of skin/subcutaneous fat/fascia/muscle, skin-only closure of abdomen, and wound packing.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 9779076
• MDR Text Key: 191987353
• Report Number: 9617613-2020-00030
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PERMACOL PRODUCT
• Device Catalogue Number: UNKNOWN PERMACOL PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2022
• 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: 03/03/2020 Patient Sequence Number: 1