MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BIOSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	UM-204
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
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, during use in patient, needle disengagement occurred.The procedure was completed with another device.The status of the patient was reported as no problem.

• Brand Name: BIOSYN
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8331511
• Report Number: 9612501-2019-00233
• Device Sequence Number: 46813
• Product Code: GAM
• UDI-Device Identifier: 10884521033368
• UDI-Public: 10884521033368
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: UM-204
• Device Catalogue Number: UM-204
• Device Lot Number: D7M1409X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1