MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGILON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	88861917-71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre operatively, the core suture was separated from the thread.
Additional Manufacturer Narrative
This event has been reassessed and found not to be associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGILON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7654625
• Report Number: 9612501-2018-01229
• Device Sequence Number: 152537
• Product Code: GAR
• UDI-Device Identifier: 20884521071619
• UDI-Public: 20884521071619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2019

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 88861917-71
• Device Catalogue Number: 88861917-71
• Device Lot Number: D7M1644X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 01/16/2019; 03/29/2019
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 02/07/2019; 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1