Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL; MESH, SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TISSUE SCIENCE LABORATORIES PERMACOL; MESH, SURGICAL Back to Search Results
Model Number P151020
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Seroma (2069); Unspecified Tissue Injury (4559)
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 hernia.It was reported that after implant, the patient experienced infected seroma and mesh failure.Post-operative patient treatment included incision and drainage of infected seroma, mesh removal, revision surgery, and hernia repair with new mesh.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERMACOL
Common Device Name
MESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
UK  GU11 1EJ
MDR Report Key10885488
Report Number9617613-2020-00083
Device Sequence Number11514894
Product Code FTM
UDI-Device Identifier10884523000177
UDI-Public10884523000177
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 Year2012
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/23/2020
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 Date05/31/2013
Device Model NumberP151020
Device Catalogue NumberP151020
Device Lot Number10B0307
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/04/2020
Initial Report FDA Received Date11/23/2020
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;
-
-