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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL; MESH, SURGICAL
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ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL; MESH, SURGICAL Back to Search Results
Catalog Number PHY1520V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem 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) 2013 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: 09/09/2021.
 
Manufacturer Narrative
Date sent to the fda: 9/21/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand Name
ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08876
MDR Report Key11084488
MDR Text Key224588505
Report Number2210968-2020-10355
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,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2015
Device Catalogue NumberPHY1520V
Device Lot NumberGK8GMGA0
Was Device Available for Evaluation? No
Date Manufacturer Received09/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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