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

Catalog Number UPLUG403

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.The cause could not be determined.No folder or mesh device was returned for evaluation.The returned opened foil package presented completely creased condition.Therefore no further evaluation could be performed.

Event Description

It was reported that during an unknown procedure, the surgeon was trying to suture in the mesh device and the device came apart.Another device of the same product code was used to complete the case.There were no patient consequences reported.

• Brand Name: ULTRAPRO COMFORT PLUG PRODUCT
• 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.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6371895
• MDR Text Key: 68814657
• Report Number: 2210968-2017-30933
• 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
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: UPLUG403
• Device Lot Number: HG8BZZZ1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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