MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 27"(70CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J365H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
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.The patient demographic info: age, gender, weight, bmi at the time of index procedure patient symptoms ¿ describe the manifestation of reaction (location, severity, appearance, systemic or local reaction) does the patient have known allergic history to medical device, food or medications? was there any allergy testing performed? if yes, results? did the patient experience an infection? if yes, were cultures performed? were there any pre-existing signs / symptoms of active infection prior to surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? other relevant patient history / concomitant medications.Lot #.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 open heart procedure on (b)(6) 2018 and suture was used to close the incision site, close to the fascia.On (b)(6) 2018, the patient returned to the doctor, complaining of an allergic reaction around the incision site.To prevent the infection from spreading to other layers of skin, the patient was prescribed antibiotics.Additional information has been requestion.

• Brand Name: VICRYL SUTURE 27"(70CM) 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: 7493000
• Report Number: 2210968-2018-72637
• Device Sequence Number: 16192030
• Product Code: GAM
• UDI-Device Identifier: 10705031039339
• UDI-Public: 10705031039339
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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 Catalogue Number: J365H
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention