• 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. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL 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. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL MESH, SURGICAL Back to Search Results
Catalog Number PHY1520V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Fever (1858); Hematoma (1884); Perforation (2001); Injury (2348); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

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) 2011 and mesh was implanted. It was reported the patient experienced an undisclosed adverse event. No additional information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
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
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10385279
MDR Text Key202208859
Report Number2210968-2020-05974
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 08/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2012
Device Catalogue NumberPHY1520V
Device LOT NumberDA8HGSA0
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 Received12/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-