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

Model Number	P151015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Injury (2348); Impaired Healing (2378)
Type of Reportable Event	Death
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.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced an open abdominal wound.Post-operative patient treatment included placement of wound vac.Information received indicates the patient is deceased.It has been stated that the death due to or is a consequence of multi-organ system failure, liver failure, pulmonary hypertension, renal failure or incarcerated ventral hernia.Information regarding the date of death is unavailable.
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 hernia.It was reported that after implant, the patient experienced an open abdominal wound.Post-operative patient treatment included placement of wound vac.Information received indicates the patient is deceased.It has been stated that the death due to or is a consequence of multi-organ system failure, liver failure, pulmonary hypertension, renal failure or incarcerated ventral hernia.Information regarding the date of death is unavailable.The device had been used with vac drain.

• Brand Name: MESH TSL - 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: 8846147
• Report Number: 9615742-2019-02745
• Device Sequence Number: 242206
• Product Code: FTM
• UDI-Device Identifier: 10884523000160
• UDI-Public: 10884523000160
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 07/01/2012
• Device Model Number: P151015
• Device Catalogue Number: P151015
• Device Lot Number: 09B0309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 10/07/2019
• 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: Death; Required Intervention