MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A PS-2 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number 1669H

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

Patient Problem Unspecified Infection (1930)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.The patient demographic info: age, gender, weight, bmi at the time of index procedure on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? what were current symptoms following the index surgical procedure? onset date? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra-op? were cultures performed? results? other relevant patient history/concomitant medications.Lot # for the ethilon suture.Will product for the same product code/lot number be returned for evaluation? 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 a carpal tunnel procedure on an unknown date and suture was used.The area around the incision was infected and the skin around the incision was red.The patient was treated with antibiotics.Additional information has been requested.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch pjj360, 1669h55 and no non-conformances were identified.

• Brand Name: ETHLN BLK 18IN 3-0 S/A PS-2 PRM MP
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9723200
• MDR Text Key: 185942135
• Report Number: 2210968-2020-01259
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031001879
• UDI-Public: 10705031001879
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 1669H
• Device Catalogue Number: 1669H
• Device Lot Number: PJJ360
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention