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

Model Number	CG-923
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 episiotomy, the device was difficult to handle and there has been an increase in the dehiscence of the raffia.In addition, the edge was quickly losing and the needle suture was loosening.Another device was used to complete the case.

• 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: 9523521
• Report Number: 9612501-2019-02528
• Device Sequence Number: 366413
• Product Code: GAL
• UDI-Device Identifier: 20884521054087
• UDI-Public: 20884521054087
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2019

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: 08/31/2020
• Device Model Number: CG-923
• Device Catalogue Number: CG-923
• Device Lot Number: D7H2752ZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1