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

Catalog Number UPA31515

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: was any issue or degradation noted in the mesh? no.How was the product stored? in an omnicell was anything stored on top of the product? no.Were there any adverse patient consequences? unknown at this time.Mesh was removed then surgical area was irrigated.Replaced with another sterile upa mesh.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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a hernia repair and mesh was used.The surgeon implanted the mesh after which it was noticed that the foil pack was punctured.The mesh was removed and a second like device was pulled and then used to complete the procedure with 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: 5806988
• MDR Text Key: 49946620
• Report Number: 2210968-2016-10613
• 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: 06/27/2016

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: 11/30/2017
• Device Catalogue Number: UPA31515
• Device Lot Number: JP9CMWA0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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