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 PHY2025V
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(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 hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 9/8/2021.Additional b5 narrative: it was reported that the patient underwent removal surgery on (b)(6) 2015 due to adhesions, erosion.It was reported that the patient experienced pain, bloating.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PHYSIOMESH
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key11757651
MDR Text Key261666985
Report Number2210968-2021-04122
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 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPHY2025V
Was Device Available for Evaluation? No
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-