• 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, 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. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1520V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994)
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. (b)(4) submitted for adverse event which occurred on (b)(6) 2012. (b)(4) submitted for adverse event which occurred on (b)(6) 2014.

 
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 removal surgery on (b)(6) 2012 during which the surgeon noted her mesh that was on the superior aspect of the recurrent incision hernia had separated from the left superior portion of the hernia and within the hernia itself. As it was crumpled up, the peritoneal aspect of the mesh was mobilized using harmonic and unruffled from the hernia sac itself. The mesh continue to roll back into the patient¿s hernia sac and explanted the portion of her mesh that continued to roll up into the hernia sac itself. It was reported that the patient underwent removal surgery on (b)(6) 2014. It was reported the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. 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, POLYMERIC
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
9082182213
MDR Report Key11467877
MDR Text Key239464767
Report Number2210968-2021-02291
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
Report Date 03/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2013
Device Catalogue NumberPHY1520V
Device LOT NumberDL8DGTA0
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 Received03/19/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2011
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: 03/11/2021 Patient Sequence Number: 1
-
-