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

Model Number	8886626771
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	08/27/2017
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, the patient, a dog, underwent an open castration procedure.The suture was being used for the closure of the abdomen and linea alba after midline laparotomy using the continuous suture technique.Post operatively, between two to ten days, the sutures for the fascia broke and lead to severe dehiscence with an open abdomen.An emergency reoperation was required with abdominal wash and re-closure of the abdominal wall, which resulted in temporary injury.The surgical time was extended by thirty minutes or more due to the product problem.The patient outcome is alive, with injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of five sutures.The visual inspection and functional evaluation of the samples had ac ceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAXON
• 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: 6947730
• Report Number: 9612501-2017-06404
• Device Sequence Number: 19031417
• Product Code: GAM
• UDI-Device Identifier: 20884523002673
• UDI-Public: 20884523002673
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K990951
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: 09/30/2020
• Device Model Number: 8886626771
• Device Catalogue Number: 8886626771
• Device Lot Number: B5J0395WX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 12/16/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 01/11/2018
• 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: 18