MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 30CMX5MM D/A CTX; CLASS I DEVICE - EXEMPT

Catalog Number RS22

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 an unknown procedure on an unknown date and suture was used.During the procedure, the suture was broken.There were no adverse patient consequences reported.

• Brand Name: MERS TAPE WHT 30CMX5MM D/A CTX
• Type of Device: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8736726
• MDR Text Key: 149261340
• Report Number: 2210968-2019-83315
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: NA
• 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
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RS22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1