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

Model Number	88861741-21
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	06/28/2018
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, during a procedure, both the needle and thread broke.The needle was detached from the suture.
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during a procedure, both the needle and thread broke.The needle was detached from the suture.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) received one device and four boxes of representative samples sealed with the appropriate packaging.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The visual inspection of the opened sample noted one suture and two needles.One needle was returned disengaged from the suture.Under microscopic inspection, normal crimp and swage marks were noted.A needle attachment test was performed on the sealed samples, and the results met the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• 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: 7685196
• Report Number: 9612501-2018-01289
• Device Sequence Number: 16370349
• Product Code: GAR
• UDI-Device Identifier: 10884521070714
• UDI-Public: 10884521070714
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K981582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/08/2019

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: 12/31/2018
• Device Model Number: 88861741-21
• Device Catalogue Number: 88861741-21
• Device Lot Number: D3M0084X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/05/2018; 12/11/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/30/2018; 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1