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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Pain (1994); Perforation (2001); 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 hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported the patient experienced an unknown event.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 09/08/2021.Additional b5 narrative: it was reported that the patient had a removal surgery on (b)(6) 2014.It was reported that the patient experienced small bowel perforation, adhesion, abscess and pain.No additional information was provided.
 
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Brand Name
PHYSIOMESH
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08876
MDR Report Key10979420
MDR Text Key220572894
Report Number2210968-2020-09787
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPHY2025V
Was Device Available for Evaluation? No
Date Manufacturer Received09/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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