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

Model Number UNKNOWN PERMACOL PRODUCT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fever (1858); Foreign Body Reaction (1868); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Perforation (2001); Scarring (2061); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fibrosis (3167); No Code Available (3191)

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 an incisional hernia. It was reported that after the implant, the patient experienced granuloma, abscess, exposed mesh, infection, failure of mesh, adhesions, injury to the bladder, open wound, recurrence, obstruction, purulent material, hole in bladder, fever, discomfort, and scarring. Post-operative patient treatment included revision surgery, wound debridements, removal of mesh, small bowel resection with primary anastamosis, hernia repair with new mesh, hole in bladder repaired, antibiotics, and enterotomies repairs.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10048241
• MDR Text Key: 191267597
• Report Number: 9617613-2020-00051
• 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
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• 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

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/01/2020
• 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: 05/12/2020 Patient Sequence Number: 1