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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 Material Disintegration (1177)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint #:(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. The product 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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported that a patient underwent a hernia repair procedure on (b)(6) 2021 and the mesh was used. It was reported that the mesh disintegrated and fell apart while attempting to suture into place. Another like device was used to complete the procedure. There were no adverse patient consequences reported.
 
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Brand NamePVP MEDIUM 6.4CM X 6.4CM
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 Key12217749
MDR Text Key263421468
Report Number2210968-2021-06637
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 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2021
Device Model NumberPVPM
Device Catalogue NumberPVPM
Device Lot NumberPKBCZTB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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