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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 PHY1015V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 ventral epigastric hernia repair surgery on (b)(6) 2011 and mesh was implanted. It was reported the patient experienced pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence. It was reported that the patient underwent additional repair surgery on (b)(6) 2016. No additional information was provided.
 
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Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12996690
MDR Text Key286431619
Report Number2210968-2021-12557
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2013
Device Catalogue NumberPHY1015V
Device Lot NumberDG8HGLA0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2011
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

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
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