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

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.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8200972
• MDR Text Key: 131585069
• Report Number: 2210968-2018-78061
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• 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 Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: PML
• Device Lot Number: V8002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/19/2019

Is This a Reprocessed and Reused Single-Use Device?