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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT; MESH, SURGICAL, POLYMERIC
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ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1520R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
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) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2011.It was reported the patient experienced adhesion and pain.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 01/05/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
Date sent to the fda: (b)(6) 2021.Additional information: d3, e1.
 
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Brand Name
ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08876
MDR Report Key11083998
MDR Text Key224747837
Report Number2210968-2020-10348
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 12/21/2020
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 Date09/30/2011
Device Catalogue NumberPHY1520R
Device Lot NumberCK9DTHZ0
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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