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 mhk493 number, and no non-conformances were identified.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 the patient underwent an unknown procedure on an unknown date and suture was used.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 adverse patient consequences reported.

• 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: 8457935
• Report Number: 2210968-2019-79740
• Device Sequence Number: 429854
• 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
• 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