MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 90CM M3; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number F2431H

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

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.Lot #? any patient consequences/ae outcome as a result of the event report? was there any medical/surgical intervention done on patient post-op to remove the broken suture from patient body? patient current condition?.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.At the ablation of the suture, the thread did not slide and that led to a breakage of the thread.A part of the thread stayed under the skin of the patient.There were no adverse patient consequences reported.Additional information has been requested.

• Brand Name: ETHILON BLK 90CM M3
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8565065
• MDR Text Key: 143572999
• Report Number: 2210968-2019-80826
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031237711
• UDI-Public: 10705031237711
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F2431H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1