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

Model Number	1669H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9723200
• Report Number: 2210968-2020-01259
• Device Sequence Number: 3220999
• Product Code: GAR
• UDI-Device Identifier: 10705031001879
• UDI-Public: 10705031001879
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention