MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 36"(90CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J371H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
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 are being 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.The patient demographic: age, weight, bmi at the time of index procedure.What were current symptoms following the index surgical procedure? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was the suture placed, interrupted or continuous? what was the appearance of the suture during the reoperation? did the wound dehisce or was the suture found broken during the second procedure? if the suture was found broken, where was the suture broken, i.E., in the middle, at the end? was there any precipitating stress factor the sutures breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? will actual product involved in the event be returned for evaluation? other relevant history / concomitant medications? 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 cesarean section on (b)(6) 2018 and suture was used.On (b)(6) 2018, the patient underwent exploratory laparotomy and found evisceration cut suture.A new suture was used to complete the procedure.Additional information has been requested.

• Brand Name: VICRYL SUTURE 36"(90CM) 1 VIO
• 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: 7694550
• Report Number: 2210968-2018-74439
• Device Sequence Number: 10974888
• Product Code: GAM
• UDI-Device Identifier: 10705031039391
• UDI-Public: 10705031039391
• Combination Product (Y/N): N
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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 Expiration Date: 10/31/2022
• Device Catalogue Number: J371H
• Device Lot Number: AJ8919
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention