MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGILENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	S8695GX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
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, on a cyst removal procedure, on two occasions, the needle fell off the suture material.Another device was used to complete the case.There was no patient injury.

• Brand Name: SURGILENE POLYPROPYLENE SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8453639
• Report Number: 9612501-2019-00614
• Device Sequence Number: 2989572
• Product Code: GAW
• UDI-Device Identifier: 20612479214693
• UDI-Public: 20612479214693
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K930587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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: 07/31/2023
• Device Model Number: S8695GX
• Device Catalogue Number: S8695GX
• Device Lot Number: D8G2777SX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR