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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PVP SMALL 4.3CM X 4.3CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PVP SMALL 4.3CM X 4.3CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PVPS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Obstruction/Occlusion (2422); 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 umbilical hernia repair surgery on (b)(6) 2016 and mesh was implanted. It was reported that the patient underwent incarcerated umbilical hernia repair surgery on (b)(6) 2018 during which the surgeon noted that ¿it was found to contain a loop of small bowel densely adherent to the undersurface of the previously placed mesh, which measured approximately 2 x 2 cm. The bowel loop was carefully dissected off the underlying mesh and the mesh sac was sent as a separate specimen. ¿ no additional information is provided.
 
Manufacturer Narrative
Date sent to fda: 1/21/2019.
 
Manufacturer Narrative
Date sent to fda: 12/20/2019. Additional narrative: it was reported that the patient underwent removal surgery on (b)(6) 2018. It was reported that the patient experienced severe pain, bowel obstruction, nausea and inflammation. (b)(4).
 
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Brand NamePVP SMALL 4.3CM X 4.3CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8205549
MDR Text Key131701446
Report Number2210968-2018-77823
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,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPVPS
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/30/2018 Patient Sequence Number: 1
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