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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PVPM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Pain (1994); Hernia (2240)
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-11122018-0000271428 submitted for adverse event which occurred on (b)(6) 2017. Mwr-11122018-0000271432 submitted for adverse event which occurred on (b)(6) 2018.
 
Event Description
It was reported by an attorney that the patient underwent epigastric ventral hernia repair surgery on (b)(6) 2016 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted that he ¿encountered an obvious draining sinus tract at the site of the mesh with fluid collection. The previously placed mesh is noted to be loose and beneath it was an obvious recurrent hernia sac. ¿ it was reported that the patient underwent an additional removal surgery on (b)(6) 2018. It was reported that the patient experienced severe pain, infection, hernia recurrence, nausea, chills, inflammation, loss of appetite, stress and anxiety. No additional information is provided.
 
Manufacturer Narrative
Date sent to fda: 08/18/2020.
 
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Brand NamePVP MEDIUM 6.4CM X 6.4CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8193223
MDR Text Key131304705
Report Number2210968-2018-77697
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 12/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPVPM
Device Catalogue NumberPVPM
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/23/2018 Patient Sequence Number: 1
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