MAUDE Adverse Event Report: ETHICON INC. GUT CHROMIC SUTURE UNKNOWN PRODUCT; SUTURE, ABSORBABLE, NATURAL

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been 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.What is the product code and lot number? did the needle fall into the patient? was the needle retrieved during the same procedure? was additional tissue incision required to retrieve the needle?.

Event Description

It was reported that a patient underwent a surgical procedure on an unknown date and suture was used.During the procedure, the suture burst and was pulling off from the needle.There were no adverse patient consequences reported.Additional information has been requested.

• Brand Name: GUT CHROMIC SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7245357
• MDR Text Key: 99191108
• Report Number: 2210968-2018-70711
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/16/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1