MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 12/27/2018

Event Type  Injury  

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.If in your possession, may we have a copy of your operative report from the initial procedure to identify what tissue layer the suture was used? can you identify the product code of the vicryl suture that was used? can you identify the product code/ name of nylon suture that was used? do you have any product for evaluation? if so, please provide your address for a shipper kit to return product.Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? this medwatch report is in response to receipt of maude event report mw5091812 reaction to vicryl captured in mw 2210968-2020-00597.

Event Description

It was reported by the patient that they underwent left knee procedure in 2018 and suture was used.The patient experienced a severe allergic reaction , noting pain, constant itching, pus drainage.On approximately (b)(6) 2018, the patient experienced blood leakage, oozing of pus, severe itching, and throbbing pin head sensation around the surgical area.The patient was prescribed an over the counter cream and steroids.The current condition of the patient is unknown.Additional information has been requested.

Manufacturer Narrative

(b)(4).What tissue layer was the nylon suture used on? no nylon used.

• Brand Name: NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9617986
• MDR Text Key: 185907160
• Report Number: 2210968-2020-00598
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention