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

Model Number P101828

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Incontinence (1928); Internal Organ Perforation (1987); Pain (1994); Injury (2348); Obstruction/Occlusion (2422)

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 gian ventral incisional hernia.It was reported that after implant, the patient experienced perforation, severe abdominal and groin pain, bowel obstructions requiring hospitalization, fecal incontinence, and dense adhesions.Post-operative patient treatment included revision surgery, small bowel resections, extensive lysis of adhesions, creation of end ileostomy and mucous fistula, exploratory laparotomy, and mesh removal.

• Brand Name: 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: 8987624
• MDR Text Key: 161735480
• Report Number: 9617613-2019-00155
• 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
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2010
• Device Model Number: P101828
• Device Catalogue Number: P101828
• Device Lot Number: 075C3-9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• 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): Required Intervention
• Patient Weight: 87