MAUDE Adverse Event Report: ETHICON INC. ETHILON* BLK 3-0 45CM (1)SC-24; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 163T

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2018.An unknown issue regarding unsatisfactory primary labeling was reported.No further information can be obtained beyond what was described.No patient consequences reported.

• 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.-BRAZIL; rodovia presidente dutra; km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8248160
• MDR Text Key: 133069260
• Report Number: 2210968-2019-78405
• Device Sequence Number: 1
• Product Code: GAR
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 163T
• Device Lot Number: AK6418
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1