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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH MESH, SURGICAL Back to Search Results
Catalog Number PHY2025V
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 a hernia repair surgery on  (b)(6) 2012  and mesh was implanted.  it was reported that the patient experienced an undisclosed adverse event. No additional information was provided.

 
Manufacturer Narrative

Additional information. Patient code: (b)(4) - surgical intervention device code: (b)(4) - hernia recurrence occured additional narrative: it was reported that patient underwent removal of mesh on (b)(6) 2013 by (b)(6) at (b)(6) due to recurrent hernia.

 
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.

 
Manufacturer Narrative

Date sent to fda: 3/6/2020, additional narrative: it was reported that the patient experienced abdominal pain, adhesions, and infections.

 
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Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL
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 Key7150533
MDR Text Key95897536
Report Number2210968-2017-71849
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 04/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2014
Device Catalogue NumberPHY2025V
Device LOT NumberEJ8HMPA0
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 Received03/05/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/01/2012
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: 12/28/2017 Patient Sequence Number: 1
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