• 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, POLYMERIC

  • 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, POLYMERIC Back to Search Results
Catalog Number PHY2025V
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Urinary Tract Infection (2120)
Event Type  Injury  
Manufacturer Narrative

To date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500 form.

 
Event Description

It was reported by an attorney that the patient underwent a laparoscopic ventral hernia repair on (b)(6) 2011 and mesh was implanted. Post-operatively it was reported that the patient experienced persistent abdominal pain, dysuria, and recurrent urinary tract infections.   on (b)(6) 2014 the patient was admitted to (b)(6) hospital in (b)(6) for recurrent urinary tract infections and dysuria. Dr. (b)(6) surveyed the patient¿s  bladder and found that the mesh had eroded into her bladder. Dr. (b)(6) found and removed a ¿foreign body greenish in hue¿ at the dome of her bladder and ¿what appeared to be an epithelialized band of bladder mucosa¿ from her bladder. On (b)(6) 2016 the patient was admitted to (b)(6) medical center, (b)(6) hospital in (b)(6) to remove the mesh that was infected and had eroded into her bladder and to treat the vesicocutaneous fistula that formed as a result of the defective mesh device. No additional information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville 08876-0151
6107428552
MDR Report Key7155686
MDR Text Key96108528
Report Number2210968-2017-72042
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,Followup
Report Date 11/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2013
Device Catalogue NumberPHY2025V
Device LOT NumberDE8HXCA0
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 Received11/28/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/01/2011
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: 12/29/2017 Patient Sequence Number: 1
-
-