MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 5-0 D/A G-3 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	792G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, when the doctor was trying to do the first pass, he put the needle through the skin and then when he went to pull up with the excess, it pulled off.It is unknown how the procedure was completed.There were no patient consequences reported.No additional information was available.

• Brand Name: GUT CHR UD 18IN 5-0 D/A G-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8458415
• Report Number: 2210968-2019-79730
• Device Sequence Number: 344381
• Product Code: GAL
• UDI-Device Identifier: 10705031011755
• UDI-Public: 10705031011755
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: 06/30/2023
• Device Catalogue Number: 792G
• Device Lot Number: MHK493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/27/2019
• Patient Sequence Number: 1