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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT; MESH, SURGICAL
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ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT; MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); 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.Mwr-25032019-0000378352 submitted for adverse event which occurred on (b)(6) 2012.Mwr-25032019-0000378389 submitted for adverse event which occurred on (b)(6) 2017.
 
Event Description
It was reported that the patient underwent a hernia repair procedure on (b)(6) 2011 and mesh was implanted.It was reported that the patient had a mesh removal surgery on (b)(6) 2017 due to abdominal pain and mesh dysfunction.No additional information was provided.
 
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Brand Name
PHYSIOMESH UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8451464
MDR Text Key139821483
Report Number2210968-2019-79644
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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