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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 Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Qgbbrt0 was reported as the lot number, but found to be invalid in the quality data base. A device upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that a patient underwent an umbilical hernia repair on (b)(6) 2021 and the absorbable straps were used. It was reported that the strap ripped off of the device. The procedure was completed with a like device with no patient consequences. There were no adverse patient consequences reported.
 
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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 08876
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 08876
9082182213
MDR Report Key11579559
MDR Text Key267477651
Report Number2210968-2021-02814
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model NumberPVPS
Device Catalogue NumberPVPS
Device Lot NumberQGBBRTD0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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