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 P101015
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Purulent Discharge (1812); Unspecified Infection (1930); Seroma (2069); Injury (2348); Impaired Healing (2378)
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 the implant, the patient experienced infected seroma, wound infection, non-healing wound and purulent/serosanginous drainage.Post-operative patient treatment included revision surgery.
 
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
GB  GU11 1EJ
MDR Report Key10319891
Report Number9617613-2020-00067
Device Sequence Number19627823
Product Code FTM
UDI-Device Identifier10884523000115
UDI-Public10884523000115
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) 07/24/2020
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 Date02/25/2013
Device Model NumberP101015
Device Catalogue NumberP101015
Device Lot Number09B3001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2020
Initial Report FDA Received Date07/24/2020
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;
-
-