MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 661G

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

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 info: age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure.The diagnosis and indication for the index surgical procedure? what skin prep was used pre-op? what were current symptoms following the index surgical procedure? onset date? were there any pre-existing signs /symptoms of active infection prior to the surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra-op? were cultures performed? results? what medical intervention was performed for the patient? results? other relevant patient history/concomitant medications.Product code and lot #.If applicable, will product be returned, return date, tracking information.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient¿s current status?.

Event Description

It was reported that the patient underwent hand surgery on an unknown date and suture was used.The incision was closed with suture.Post-op, the patient returned with redness and infection about one centimeter around the incision.The doctor prescribed antibiotics and the redness and infection cleared up a few days later.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 2/5/2020.Additional information: d1, d4, g1, h4, h6.A manufacturing record evaluation was performed for the finished device batch lmj090 and no non-conformances were identified.Additional information was requested and the following was obtained: i have just received this information from the account.That is the only other information: 5-0 nylon is 661g lot #lmj090.

• Brand Name: ETHILON SUTURE 18"(45CM) 5-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9548635
• MDR Text Key: 185904480
• Report Number: 2210968-2020-00088
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 661G
• Device Lot Number: LMJ090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention