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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PHYSIOMESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1015V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Pain (1994); Hernia (2240); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative

Date sent to the fda: 03/05/2021. 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 that the patient underwent a recurrent hernia during which the surgeon noted she lysed the adhesions in the anterior abdominal wall. It was reported the patient experienced pain, discomfort, and diarrhea. No additional information was provided.

 
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Brand NamePHYSIOMESH
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 Key11426709
MDR Text Key241413290
Report Number2210968-2021-02048
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 03/03/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2013
Device Catalogue NumberPHY1015V
Device LOT NumberDB8GPPA0
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 Received03/08/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/11/2011
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

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