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

Model Number	P151828
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Injury (2348); Impaired Healing (2378); Ascites (2596); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• MDR Report Key: 7034376
• Report Number: 9615742-2017-05741
• Device Sequence Number: 19032452
• Product Code: FTM
• UDI-Device Identifier: 10884523000191
• UDI-Public: 10884523000191
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 05/22/2019; 05/22/2019
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/19/2019; 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention