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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 Pain (1994); Hernia (2240); Not Applicable (3189)
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 procedure on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent mesh removal on (b)(6) 2016 due to hernia recurrence and pain.No additional information was provided.
 
Manufacturer Narrative
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: 7/7/2021.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 Key10474061
MDR Text Key205071386
Report Number2210968-2020-06492
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 foreign,other
Type of Report Initial,Followup,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2015
Device Catalogue NumberPHY1520R
Device Lot NumberGJ8GJLA1
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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