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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 P151520
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Perforation (2001); Discharge (2225); Hernia (2240); Peritonitis (2252); Injury (2348); Impaired Healing (2378); Blood Loss (2597); 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. The product was used for therapeutic treatment of a hernia. It was reported that after implant, the patient experienced excision of prior incisional hernia mesh, recurrent incisional hernia repaired with new mesh. There was stool coming out from the hernia repair incision confirmed colonic perforation and fecal contamination around the hernia repair site, significant infection of abdominal wall, infected hematoma in lower abdomen, bowels were adhered, there were several pockets of abscesses, lysis of adhesions, chronic abscess with pus in left upper quadrant, debridement of abdominal wall, infected soft tissue and abscess, there was some necrosis in the area, there was presence of the mesh in this location caused chronic infection which did not allow the wound to heal. Post-operative patient treatment included additional surgery.
 
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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
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 Key8458070
MDR Text Key140081533
Report Number9617613-2019-00024
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberP151520
Device Catalogue NumberP151520
Device Lot NumberAOG0663
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/29/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2019 Patient Sequence Number: 1
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