MAUDE Adverse Event Report: ETHICON INC. GUT PLAIN SUTURE 18"(45CM) 6-0 UND; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1916G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What do you mean by "the stitches opened" ? did the suture knots untie in the post operative period? or did the suture knots untie in the intra operative period? was procedure completed successfully? and how? was there any medical or surgical intervention performed? confirm if any patient consequences / ae report as a result of the issue?.
Event or Problem Description
It was reported that the patient underwent a blephoplasty procedure and suture was used.It was reported that the stitches opened post operatively.There were no patient consequences reported.Additional information has been requested.

• Brand Name: GUT PLAIN SUTURE 18"(45CM) 6-0 UND
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7185771
• Report Number: 2210968-2018-70240
• Device Sequence Number: 16453175
• Product Code: GAL
• UDI-Device Identifier: 10705031002920
• UDI-Public: 10705031002920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: 05/31/2021
• Device Catalogue Number: 1916G
• Device Lot Number: KGM557
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1