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

Model Number	88861741-21
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	11/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, pre-operatively, as soon as the suture was opened, the thread was detached form the needle.No patient involved.

• Brand Name: DERMALON
• 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: 6855874
• Report Number: 9612501-2017-06112
• Device Sequence Number: 891492
• Product Code: GAR
• UDI-Device Identifier: 20884521070711
• UDI-Public: 20884521070711
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2017

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: 04/30/2021
• Device Model Number: 88861741-21
• Device Catalogue Number: 88861741-21
• Device Lot Number: D6D2860X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1