• 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 P100205
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Scarring (2061); Hernia (2240); Injury (2348)
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 laparoscopic therapeutic treatment of a paraesophageal hiatal hernia. It was reported that after the implant, the patient experienced mesh failure, pain, adhesions, scarring, and recurrence. Post-operative patient treatment included revision surgery, lysis of adhesions, left and right sliding rectus myofascial advancement flaps, hernia repair with new mesh, left and right adipocutaneous skin flaps, adjacent tissue transfer closure of abdominal wall defect, left and right adipocutaneous skin flaps, and removal of mesh.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERMACOL
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 Key10174105
MDR Text Key195744928
Report Number9615742-2020-01325
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberP100205
Device Catalogue NumberP100205
Device Lot NumberAOJ0998
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/03/2014
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: 06/19/2020 Patient Sequence Number: 1
-
-