MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Catalog Number PHSM

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Photo has been returned.A supplemental medwatch will be sent upon completion of analysis of photo.Attempts are being made to obtain the following information.  to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify the number of packages that were found open before use.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and mesh was used.Pre-operatively the mesh package was found opened before use.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: an opened sample was returned for analysis.During visual inspection of the sample, the seal area in the packet present inconsistency in the sealing area and the sterile barrier was compromised.Per the condition of the returned sample, the assignable cause of the reported event is an open seal.

Manufacturer Narrative

Additional summary: there was no sample received for analysis.Only a picture of the sample was received for analysis.Upon visual inspection of the picture, a sample of product code phsm lot# 3165j08 could be observed.However, no conclusion could be reached as to the origin of the foreign matter as the sample was not returned for analysis.

• Brand Name: PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY
• 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: 8341097
• MDR Text Key: 136250364
• Report Number: 2210968-2019-78889
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048997
• UDI-Public: 10705031048997
• Combination Product (y/n): N
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: PHSM
• Device Lot Number: 31651J08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Date Manufacturer Received: 04/03/2019
• Patient Sequence Number: 1