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: ETHICON INC. PHYSIOMESH; 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
 

ETHICON INC. PHYSIOMESH; MESH, SURGICAL Back to Search Results
Catalog Number PHY1015V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burning Sensation (2146); Hernia (2240); Injury (2348); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
Date sent to fda: 7/17/2019.(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2015 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
 
Manufacturer Narrative
Patient code: 3189- surgical intervention.It was reported that the patient underwent mesh removal on (b)(6) 2018 due to hernia recurrence and burning sensation.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PHYSIOMESH
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8797179
MDR Text Key151266860
Report Number2210968-2019-84315
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2016
Device Catalogue NumberPHY1015V
Device Lot NumberJA8BWBB0
Was Device Available for Evaluation? No
Date Manufacturer Received11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-