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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE* POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PML
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2018
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. Attempts are being made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent an unknown procedure on an unknown date and mesh was used. After opening the box, the secondary packaging was found open. There were no adverse patient consequences reported.
 
Manufacturer Narrative
(b)(4). Date sent to the fda: 02/14/2019. Additional: pml lot v8002 received in opened condition. Actual sample consisted of 1 opened folder with mesh and sbf. Tamper proof stickers were checked and found peeled-off at the time of opening. Retained samples of the incident code and lot was retrieved for visual inspection. The primary folder of retain samples were visually inspected for presence of desired pack components and found satisfactory. All the retain samples were visually checked for package integrity and observed sealed from all sides. Seal strength reports at the time of release were checked and results were within the specification limits. This is one and isolated case.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8200972
MDR Text Key131585069
Report Number2210968-2018-78061
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031049031
UDI-Public10705031049031
Combination Product (y/n)N
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPML
Device Lot NumberV8002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2019
Is This a Reprocessed and Reused Single-Use Device?

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