• 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 Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria. Summary: an empty opened foil and a mesh were returned for analysis. During visual inspection of the mesh, damaged and delamination on the proceed top were observed. Per the sample condition, the assignable cause of performance damaged product, is delamination.
 
Event Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and the mesh was implanting. During implantation, it was noticed that the mesh had a defect on the abdominal side of the mesh. Another like mesh was implanted during the procedure. During evaluation of the returned device, damaged and delamination on the proceed top were observed. There were no patient consequences reported.
 
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 INC.-GMBH
robert-koch strasse 1
norderstedt
GM
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8604454
MDR Text Key144849140
Report Number2210968-2019-81320
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberPVPM
Device Lot NumberLM8BZQB0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
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

-
-