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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 P101010
Medical Device Problem Codes Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Scarring (2061); Injury (2348)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hiatal hernia.It was reported that after implant, the patient experienced mesh "folded over the anterior esophagus," mesh migration and scarring.Post-operative patient treatment included two removal surgeries.
 
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Brand Name
PERMACOL
Common Device Name
MESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB  GU11 1EJ
MDR Report Key9800102
Report Number9617613-2020-00038
Device Sequence Number610334
Product Code FTM
UDI-Device Identifier10884523000108
UDI-Public10884523000108
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K120605
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/31/2012
Device Model NumberP101010
Device Catalogue NumberP101010
Device Lot Number09B0808
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/19/2020
Initial Report FDA Received Date03/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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