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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 P151020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930); Necrosis (1971); Injury (2348); Impaired Healing (2378); 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 hernia. It was reported that after implant, the patient experienced abdominal wound infection, irrigation/debridement of abdominal wall wound with panniculectomy, infected and necrotic skin, necrosis extended more extensively underneath the surface of the skin and the abscessed tissue was excised. Post-operative patient treatment included revision 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 Key8465111
MDR Text Key140329000
Report Number9617613-2019-00029
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,Followup,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2007
Device Model NumberP151020
Device Catalogue NumberP151020
Device Lot Number05B19-9
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: 03/29/2019 Patient Sequence Number: 1
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