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

Model Number	CL-823
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fistula (1862)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, post operatively, there was more often intolerance reactions appeared with formation of subcutaneous fistulas.One closed blister of a dog showed 8 days after surgery wound dehiscence over more than 1 cm with urine run-off into the abdominal cavity.Suture was used for several laparotomies and often reactions and fistula formation appeared.Vet had no problems of this kind with other sutures.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of twenty-five devices.The visual inspection and functional evaluation of the samples had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.A review of the device history record indicates the product was released meeting all manufacturer's quality release specifications at the time of manufacture.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: POLYSORB
• 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: 6900419
• Report Number: 9612501-2017-06281
• Device Sequence Number: 1364998
• Product Code: GAM
• UDI-Device Identifier: 20884521042152
• UDI-Public: 20884521042152
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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: 06/30/2021
• Device Model Number: CL-823
• Device Catalogue Number: CL-823
• Device Lot Number: A6F0598X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1