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

Catalog Number	7770G
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown ophthalmic surgery on an unknown date and suture was used.When passing the needle through the tissue, adhesive like substance remained on the tissue.It was hard to remove the adhesive like substance.There were no adverse consequences to the patient.

• Brand Name: ETHILON SUTURE 12"(30CM) 10-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8496161
• Report Number: 2210968-2019-80147
• Device Sequence Number: 11038791
• Product Code: GAR
• UDI-Device Identifier: 10705031010963
• UDI-Public: 10705031010963
• Combination Product (Y/N): N
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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
• Operator of Device: No Information
• Device Catalogue Number: 7770G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1