MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 54IN 3-0 D/A CT,FSL; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J940H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); No Code Available (3191)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot pb5343, 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.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, weight, bmi at the time of index procedure.What was the name of the initial procedure? what tissue was the suture used on? what was the condition of the tissue (ie normal or thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? patient symptoms manifestations (location, severity, appearance, systemic or local reaction)? were any cultures performed on the secretion? if so, what were the results? what was the indication for prescribing antibiotics to the patient? what medical/surgical intervention was provided to manage the patient symptoms? will the device or sample from lot pb5343 be returned for evaluation? 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 a patient underwent an unknown surgery on (b)(6) 2020 and suture was used.Following the procedure, the patient experienced wound secretion.During a check on (b)(6) 2020, it was found that the wound dressing was wet and there was liquid exudation.The yellow fluid could flow out of the incision.The doctor in charge considers suture reaction.After that, the use time of antibiotics was prolonged for 3 days, and cleaning and dressing change were given at regular intervals every day.The patients condition changes better until (b)(6) 2020.Additional information has been requested.

• Brand Name: VCL CT BRD UD 54IN 3-0 D/A CT,FSL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9813194
• Report Number: 2210968-2020-01884
• Device Sequence Number: 2769935
• Product Code: GAM
• UDI-Device Identifier: 10705031043626
• UDI-Public: 10705031043626
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/14/2020

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: 01/31/2024
• Device Model Number: J940H
• Device Catalogue Number: J940H
• Device Lot Number: PB5343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention