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

Model Number P151828

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Injury (2348); Impaired Healing (2378); Ascites (2596); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Pre-operative and post-operative diagnosis: incarcerated ventral (incisional) hernia.Procedure: 1.Laparoscopy diagnostic.2.Open repair of ventral hernia (incisional hernia) with biological mesh size 18 cm x 28 cm 1.5 mm thick.3.Small bowel resection with side-to-side anastomosis.4.Extensive lysis of adhesion.Events: the patient had surgical revisions, abscess, and pain.

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 ventral incisional hernia.It was reported that after the implant, the patient experienced an abscess, adhesions, healing impaired, intraabdominal fluid collection, scar, previous mesh causing a sinus tract and pain.Post-operative patient treatment included surgical revision, abscess irrigation, wound vac, small bowel resection with side to side anastomosis, extensive lysis of adhesions, removal of old mesh, abdominal wall reconstruction with flap raised bilaterally, drain placement x 2, vac placement, debridement of abdominal wall abscess and placement of wound vac.

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.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 incisional hernia.It was reported that after the implant, the patient experienced an abscess, adhesions, healing impaired, and pain.Post-operative patient treatment included surgical revision, abscess irrigation, wound vac, small bowel resection with side to side anastomosis, and extensive lysis of adhesions.

• 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: 7034376
• MDR Text Key: 92099673
• Report Number: 9615742-2017-05741
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000191
• UDI-Public: 10884523000191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: P151828
• Device Catalogue Number: P151828
• Device Lot Number: AOJ0289
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Date Device Manufactured: 10/11/2014
• 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; Required Intervention