MAUDE Adverse Event Report: ETHICON INC. ETHICON COTTON UMBILICAL TAPE

Catalog Number U11T

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and cotton umbilical tape was used.The product was cut in half.The surgeon was unable to locate one half of the product and was not certain whether the product was retained in the patient.

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: ETHICON COTTON UMBILICAL TAPE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4074564
• MDR Text Key: 4747397
• Report Number: 2210968-2014-12513
• Device Sequence Number: 1
• Product Code: GAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: U11T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other