MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CHROMIC GUT; SUTURE, ABSORBABLE, NATURAL

Model Number	UG-202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2018
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, pre-operatively, when the device was opened and being prepared, the thread broke.There was no patient involvement.

• Brand Name: CHROMIC GUT
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7443171
• Report Number: 9612501-2018-00792
• Device Sequence Number: 11066854
• Product Code: GAL
• UDI-Device Identifier: 10884521056138
• UDI-Public: 10884521056138
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K885018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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: 07/31/2020
• Device Model Number: UG-202
• Device Catalogue Number: UG-202
• Device Lot Number: D5G0400NX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1