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

Model Number	GL-46-MG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
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 hemangioma resection of the left upper arm, the patient wound was suture with the device, however the needle broke three quarters of which were under the incision and one quarter were on the suture line.After finding the broken needle, the doctor found three-quarters of the broken needle under the incision.After taking it out, the doctor checked the whole needle with the nurse under the stage and confirmed that the two broken ends were a good needle.There was no patient injury.

• Brand Name: POLYSORB
• 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: 9943922
• Report Number: 9612501-2020-00632
• Device Sequence Number: 11501404
• Product Code: GAM
• UDI-Device Identifier: 10884521045354
• UDI-Public: 10884521045354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2020

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: 06/30/2024
• Device Model Number: GL-46-MG
• Device Catalogue Number: GL-46-MG
• Device Lot Number: D9G2332Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 MO