MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMM3

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information requested and following was obtained: please clarify if this complaint is for suture or mesh? mesh.Please clarify a lot number for all three devices of prolene mesh? unk.Did the 3 devices come from the same secondary package? unk.Confirm that the seal of the primary package was opened, not intact on all three pmm3 devices resulting in device exposure to the environment and loss of device sterility? all 3 device with sterile package open.It was reported devices not used on the patient.Tell us how the procedure was completed? confirm no patient consequences? unk.Provide name of scheduled procedure? unk.It was reported no devices are returning, customer is retaining products.Please confirm that 0 devices are being returned.0 device will be returned back.Note: same events for other two same devices were reported via 2210968-2019-79936 and 2210968-2019-79935.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and the mesh was implanted.During the procedure, it was noticed prior to use on the patient that the patch/mesh was not packed tightly; one side was not sealed.The mesh was not used on the patient; another like device was used to complete the procedure.Additional information has been requested.

• Brand Name: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8476686
• MDR Text Key: 140743850
• Report Number: 2210968-2019-79937
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: PMM3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1