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

Model Number	CG-905
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary (b)(6) 5.4 report immediately, but no later than 30 days.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when the surgeon tried to suture the tissue on a caesarean section procedure, the needle refused to penetrate the tissue.The surgeon used another suture to complete the case.There was no patient injury.

• 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: 7455741
• Report Number: 9612501-2018-00837
• Device Sequence Number: 16384445
• Product Code: GAL
• UDI-Device Identifier: 10884521054011
• UDI-Public: 10884521054011
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 10/31/2020
• Device Model Number: CG-905
• Device Catalogue Number: CG-905
• Device Lot Number: D5K1409X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1