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

Model Number	8886664141
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/16/2019
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 a lobectomy, the suture pulled off the needle.They opened a new device to complete the case.

• 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: 8591615
• Report Number: 9612501-2019-00930
• Device Sequence Number: 16692571
• Product Code: GAM
• UDI-Device Identifier: 10884523004151
• UDI-Public: 10884523004151
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

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: 10/31/2023
• Device Model Number: 8886664141
• Device Catalogue Number: 8886664141
• Device Lot Number: D8K1052FX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR