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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES PERMACOL MESH, SURGICAL Back to Search Results
Model Number P151520
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Discomfort (2330); Unspecified Tissue Injury (4559)
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 the implant, the patient experienced recurrence, adhesions, pain, and discomfort. Post-operative patient treatment included revision surgery, hernia repair with new mesh, hernia sac resected, and admission to icu.
 
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Brand NamePERMACOL
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
gu11 1ej
aldershot, hampshire
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
gu11 1ej
aldershot, hampshire
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 
2034925563
MDR Report Key10841774
MDR Text Key216319475
Report Number9617613-2020-00079
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
Report Date 11/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model NumberP151520
Device Catalogue NumberP151520
Device Lot NumberAQG0641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/20/2016
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: 11/15/2020 Patient Sequence Number: 1
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