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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 PHY2025V
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Hernia (2240); 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 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 repair of an incarcerated ventral hernia on (b)(6) 2014 and mesh was implanted. On (b)(6) 2015 the patient underwent an invasive surgical procedure at (b)(6) hospital in (b)(6), for recurrence of his  incarcerated large and small bowel ventral hernia and removal of the mesh. It was reported that the physician noted that the mesh was protruding into the hernia sac with omental adhesions, necessitating removal of the mesh as well as additional surgical repair of the same hernia it was implanted to treat.

 
Manufacturer Narrative

In addition, a device history review has been inserted into the file. This review indicates that there was no quality concerns associated with the manufacturing process.

 
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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
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7155732
MDR Text Key96109233
Report Number2210968-2017-72043
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 06/24/2019
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 Date04/30/2016
Device Catalogue NumberPHY2025V
Device LOT NumberHE8GCWB0
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 Received06/24/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/01/2014
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
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