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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿ MESH, SURGICAL Back to Search Results
Model Number P101010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); 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. Preoperative diagnosis was incarcerated ventral hernia and high-grade partial small bowel obstruction and post-op diagnosis was incarcerated ventral hernia, the incarceration being greater omentum and dilated proximal small bowel and synthetic mesh, high-grad small bowel obstruction secondary to the second hernia, which was a richter type hernia separate from the large ventral hernia. The procedure performed was reduction and repair of incarcerated ventral hernia with biologic implant, placement implant, reduction and repair of incarcerated richter hernia which was a separate hernia from the main ventral hernia and it was the cause of the high-grade partial small bowel obstruction and removal of old mesh. On (b)(6) 2017 - the patient underwent surgical revision of repair of ventral hernia and placement of mesh. The pre-op and post-op diagnosis was ventral hernia and morbid obesity. On (b)(6) 2017 - the patient underwent a subsequent procedure for incisional hernia repair with mesh and umbilectomy. The pre-op and post-op diagnosis was incisional hernia and morbid obesity. The patient experienced multiple surgical revisions, lysis of adhesions to previous mesh, recurrence, pain, and bowel obstruction.
 
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 an incarcerated ventral hernia with biologic implant and the reduction and repair of incarcerated richter hernia. It was reported that after implant, the patient experienced recurrence, adhesions, pain and bowel obstruction. Post-operative patient treatment included underwent surgical revision, recurrence repair, lysis of adhesions and placement of new mesh.
 
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 an incarcerated ventral hernia with biologic implant and the reduction and repair of incarcerated richter hernia. It was reported that after implant, the patient experienced recurrence, adhesions, pain, seroma, and bowel obstruction. Post-operative patient treatment included underwent surgical revision, recurrence repair, lysis of adhesions, and placement of new mesh.
 
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Brand NameMESH TSL - PERMACOL¿
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
MDR Report Key7402686
MDR Text Key104555790
Report Number9615742-2018-00800
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberP101010
Device Catalogue NumberP101010
Device Lot NumberAOL0561
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/06/2018 Patient Sequence Number: 1
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