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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
Model Number PVPS
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Attempts are being made to obtain the following information.  to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Please provide procedure name and date please explain in detail what was the issue with the device. What do you mean by "tabs on mesh failed", did the straps tear off during the procedure? please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail how was procedure successfully completed? please provide lot number.
 
Event Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2021 and the mesh was used. It was reported that the tabs on the mesh failed when the mesh was inserted into patient and pulled. It was reported that the mesh would not sit flat. The mesh discarded as it was contaminated. There were no adverse consequences reported. Additional information was requested.
 
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Brand NamePVP SMALL 4.3CM X 4.3CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12353716
MDR Text Key267668489
Report Number2210968-2021-07591
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPVPS
Device Catalogue NumberPVPS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
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?
Type of Device Usage Initial

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