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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 Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Laceration(s) (1946); Internal Organ Perforation (1987); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); Blood Loss (2597)
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 laparoscopic therapeutic treatment of a recurrent ventral hernia. It was reported that after implant, the patient experienced recurrence, extensive adhesions, serosal tears, abscess in left lateral abdominal area, leakage, and bleeding. Post-operative patient treatment included recurrent incisional hernia repair with new bard mesh, omentum and small bowel attached to the inferior aspect of the mesh were dissected, all segment of composite mesh extended to below the umbilicus at the midline was excised, placement of bard mesh, bowel was teased off of the mesh and the abdominal wall, repair of serosal tears, removal of previous mesh, placement of new covidien permacol mesh, drainage of intrabdominal abscess as well as three areas of small bowel required resection: part that had leaked, torn during lysis of adhesions, and was devascularized from tearing and having bleeding.
 
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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 Key8515443
MDR Text Key141969589
Report Number9617613-2019-00052
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2013
Device Model NumberP151520
Device Catalogue NumberP151520
Device Lot Number10B1209
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/15/2019 Patient Sequence Number: 1
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