• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PVPM
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

 
Event Description

It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2018 and mesh was used. During the procedure, the tabs pulled away from the mesh while the surgeon was attempting to place the mesh in the patient. A like device was used to complete the procedure. There were no adverse patient consequences reported. No additional information was provided.

 
Manufacturer Narrative

Date sent to the fda: 08/01/2018 additional summary: the actual sample was returned for evaluation. During visual inspection of the used sample, body fluids on the implant and partial detachment of the wings from load ring was observed at the device. In addition, there are several fragments of the pds base plate present, indicating significant degradation. The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch. Per the sample condition, it could not be determined what may have caused the reported incident.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
ETHICON GMBH
p.o. box 1409 d22841
norderstedt
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7652403
MDR Text Key112849719
Report Number2210968-2018-73955
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061533
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 06/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2019
Device Catalogue NumberPVPM
Device LOT NumberLM8GQHB0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-