MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO PLUG; MESH, SURGICAL, POLYMERIC

Catalog Number UPPM1

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Attempts have been made to retrieve the device.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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.It was reported that when the doctor using the uppm1 in hernia repair procedure, the onlay and underlay of plug occur separate.We would like to know what you are referring to when you say "occur separate" do you mean item ¿came apart¿ ? if it came apart there are multiple components in the product for example (see below) and clarify? a possibility could be that the pds rib has separated from the plug.Or did fibres separate from the onlay mesh? the lot number was not marked as unknown please provide only the lot number of this reported device? was the device in use on the patient when the difficulty was noted or was the difficulty noted upon opening the sterile package?.

Event Description

It was reported that the patient underwent a hernia repair procedure on (b)(6) 2017 and the mesh was implanted.During the procedure, the onlay and underlay of mesh occurred separate.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

An opened foil with a mesh patch inside of the product code uppm, lot # kp8blhc0 were returned for analysis.During the visual inspection of the sample, the opened foil was examined and presented excessive handling and the seal area the foil packet was conforming to requirements and only the patch was observed inside.The ultra plug medium device was not observed.It could not be determined what may have caused the reported incident.

• Brand Name: ULTRAPRO PLUG
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 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 08876-0151 ; 9082182792
• MDR Report Key: 6901751
• MDR Text Key: 87807698
• Report Number: 2210968-2017-70375
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K070224
• 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,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: UPPM1
• Device Lot Number: KP8BLHC0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1