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

Model Number	GMM-563L
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	08/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during unpacking the suture.The needle and the suture thread were separated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during unpacking the suture.The needle and the suture thread were separated.Replaced the device to complete the procedure.

• Brand Name: MAXON
• 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: 6856182
• Report Number: 9612501-2017-06115
• Device Sequence Number: 16334083
• Product Code: GAM
• UDI-Device Identifier: 20884521128603
• UDI-Public: 20884521128603
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K990951
• 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,Followup
• Report Date (Section B): 06/22/2018

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: 08/31/2021
• Device Model Number: GMM-563L
• Device Catalogue Number: GMM-563L
• Device Lot Number: D6H1643X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1