MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 5-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y490G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? what is meant by sto? the diagnosis and indication for the index surgical procedure? date - time of onset of infection from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? were cultures performed? results? lot number? other relevant patient history/concomitant medications? if applicable, will product be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.
Event or Problem Description
It was reported that the patient underwent carpal tunnel procedure on an unknown date and suture was used.The suture was placed subcuticularly during operation with the knots tied on the outside.Knots were cut post-op 15 days in the clinic.After which, patient developed an infection (staph a) after sto of suture in clinic.Additional information has been requested.

• Brand Name: MCRYL UD 18IN 5-0 S/A P-1 PRM
• 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: 8780642
• Report Number: 2210968-2019-84101
• Device Sequence Number: 1937556
• Product Code: GAN
• UDI-Device Identifier: 10705031059283
• UDI-Public: 10705031059283
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: Y490G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2019
• Initial Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention