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 Codes	Wound Dehiscence (1154); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.If further details are received at the later date a supplemental medwatch will be sent.Date and name of index surgical procedure.The diagnosis and indication for 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 intervention was performed for this suture event? what date did the patient present with evisceration (# of post-op days)? did the tissue separate from the suture or did the suture break post-operatively? how was the evisceration managed? if surgical intervention was performed, what was the appearance of the suture during the second procedure? will device involved in the event be returned for evaluation? what is the patient¿s current status? please confirm the specific number of patient events.Have any of these events been previously reported to ethicon? if yes, please provide complaint file number/ affiliate number.For each patient event please provide: -event date.-patient demographics (initials/id, age or dob), -date and name of procedure.-event description.-was there any adverse patient outcome? -if yes, was there any medical or surgical intervention performed?.
Event or Problem Description
It was reported that patient underwent an unknown procedure on unknown date and suture was used.The patient experienced wound dehiscence, possible evisceration.The current condition of the patient is unknown.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: 7723545
• Report Number: 2210968-2018-74643
• Device Sequence Number: 1474672
• Product Code: GAM
• UDI-Device Identifier: 10705031039391
• UDI-Public: 10705031039391
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K022269
• 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): 07/03/2018

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: 07/03/2018
• Initial Report FDA Received Date: 07/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention