MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 12"(30CM) 10-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 9007G

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Can you please provide a photo of the product box? exactly which description on the product box was different than the 'old' box?.

Event Description

It was reported that on an unknown date, while adjusting inventory at the healthcare facility, it was noticed that the description on the new box was slightly different from the description on the old box.There was no patient involvement and no adverse patient consequences.Additional information has been requested.

• Brand Name: ETHILON SUTURE 12"(30CM) 10-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7407625
• MDR Text Key: 105315301
• Report Number: 2210968-2018-72011
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031022393
• UDI-Public: 10705031022393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9007G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• 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