• 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 Adhesion(s) (1695); Hernia (2240); Injury (2348); Not Applicable (3189)
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) 2012 and mesh was implanted. It was reported that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted. It was reported the patient experienced an undisclosed adverse event. Other procedures are captured under separate files. No additional information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10553954
MDR Text Key207543047
Report Number2210968-2020-07069
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2013
Device Catalogue NumberPHY1015V
Device LOT NumberED8JRHA0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/18/2020 Patient Sequence Number: 1
-
-