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

Model Number	8886624561
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Tissue Damage (2104); Injury (2348); No Code Available (3191)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According the reporter, pre-operatively, the thread part of the product was broken after 2-10 days.The surgeon employed continuous suture.There was a temporary injury to the patient related to wound dehiscence with open abdomen.Reoperation was done approximately 3 days post op with abdominal wash and re-closure of abdominal wall was necessary.The patient (dog) was alive with injury.

• 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: 6943775
• Report Number: 9612501-2017-06392
• Device Sequence Number: 16446280
• Product Code: GAM
• UDI-Device Identifier: 10884523002492
• UDI-Public: 10884523002492
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2017

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: 12/31/2020
• Device Model Number: 8886624561
• Device Catalogue Number: 8886624561
• Device Lot Number: D5M0931X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 30