MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL ULTRAPRO PLUG; MESH, SURGICAL, POLYMERIC

Catalog Number UPPM2

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent to the fda: 06/20/2017.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 laparoscopic inguinal hernia repair on (b)(6) 2017 and mesh was used.During the procedure, the plug anchor ripped away from the rim prior to fixation.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

We received for evaluation an opened ultrapro plug of the product code uppm2 (an onlay patch, a rim/body and an anchor).During visual inspection of the open sample it was observed body fluids on the implant mesh and the anchor and body was not connected; since the anchor was pull out of the body.In addition, the rim of the implant mesh present damaged.The onlay patch no present damaged or body fluids.It was observed that during our investigation the components present initial disintegration on the absorbable part of the mesh.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): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6653886
• MDR Text Key: 78042632
• Report Number: 2210968-2017-60288
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: UPPM2
• Device Lot Number: KL8CMHC0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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