MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 5-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J493H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 is meant by the needle was excised from patient? initial procedure date.Procedure name.When was the needle excised from the patient (during the initial surgery or was the patient brought back to or)? location that the needle was located? size of incision to remove the needle? was there any adverse patient outcome? what is meant by in another instance the suture broke off ? did the needle pull off the suture?.
Event or Problem Description
It was reported that a patient underwent a dermatology procedure on an unknown date and suture was used.It was reported that the needle pulled off while being used by the physician to suture a patient.The needle may have been excised from the patients skin.There were no adverse consequences for the patient.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and the following was obtained: procedure name: procedure was called mohs micrographic surgery.Initial procedure date for each patient event: procedure date can¿t remember, but within last 2 months.When was the needle excised from the patient (during the initial surgery or was the patient brought back to or)? needle excised from patient during the procedure.Location that the needle was located? brow and temple.Size of incision to remove the needle? 1-1.5cm.Was there any adverse patient outcome? no adverse outcome for patient.

• Brand Name: VICRYL SUTURE 18"(45CM) 5-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8591884
• Report Number: 2210968-2019-81182
• Device Sequence Number: 16662578
• Product Code: GAM
• UDI-Device Identifier: 10705031040502
• UDI-Public: 10705031040502
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: No Information
• Device Catalogue Number: J493H
• Device Lot Number: MBK575
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1