MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 8-0 D/A TG100-8; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1714G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts have been 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 or Problem Description
It was reported that a patient underwent a blepharoplasty on (b)(6) 2018 and suture was used.During the procedure, the needle popped off the suture.The procedure was completed with another like device.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: ETHLN BLK 12IN 8-0 D/A TG100-8
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7776359
• Report Number: 2210968-2018-75091
• Device Sequence Number: 13767829
• Product Code: GAR
• UDI-Device Identifier: 10705031002241
• UDI-Public: 10705031002241
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 1714G
• Device Lot Number: LE6974
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/13/2018
• Patient Sequence Number: 1