MAUDE Adverse Event Report: ETHICON INC. ETHILON*BLACK10-0 15 (1)TG1408; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 7618G

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).The photo upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.

Event Description

It was reported that a patient underwent an unknown procedure on unknown date and suture was used.The suture thread was reported as significantly reduced in size.There were no patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).The picture of the alleged package was provided and not actual reported device.As no sample was returned for analysis.We are unable to investigate further the issue of suture diameter.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.A manufacturing record evaluation was performed for the finished device am2866 number, and no non-conformances were identified.The following information was requested, but unavailable: what do you mean by "reduced in size" ??? please clarify the following:---was there any difference noticed with the length of the suture or ---- was there any difference noticed with the diameter of the suture? do you have any actual suture picture as reported in event?.

• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9258222
• MDR Text Key: 196226508
• Report Number: 2210968-2019-89265
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7618G
• Device Lot Number: AM2866
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Patient Sequence Number: 1