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

Model Number	CG-172
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, sutures were not absorbing and caused infections.Sutures that have been in place for over a month have been taken out when they were supposed to dissolve in about 2 weeks.

• Brand Name: PLAIN GUT
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• MDR Report Key: 11331569
• Report Number: 9612501-2021-00258
• Device Sequence Number: 1034819
• Product Code: GAL
• UDI-Device Identifier: 00884521053581
• UDI-Public: 00884521053581
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K885018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: CG-172
• Device Catalogue Number: CG-172
• Device Lot Number: D0J2421ZY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention