MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	CL-823
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, a canine patient had a midline incision for a ovariohysterectomy.A simple continuous suture of the polysorb was placed in the muscle and sub-cutaneous then supramid in the skin.She was checked on the (b)(6) and everything was fine.On the (b)(6), she came back and the breakdown was found.The wound would have been 7-10cm long.Owners insisted that the dog was rested at home post-surgery.Patient had to be re-stitched, thus incurring further costs for drugs, consumables, theatre time and aftercare - owners have asked if medtronic would be willing to pay for the additional costs incurred.
Additional Manufacturer Narrative
This product event is not reportable.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): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6715943
• Report Number: 1219930-2017-05998
• Device Sequence Number: 1267784
• Product Code: GAM
• UDI-Device Identifier: 20884521042152
• UDI-Public: 20884521042152
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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: 01/31/2022
• Device Model Number: CL-823
• Device Catalogue Number: CL-823
• Device Lot Number: A7A0457X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 07/24/2017
• 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: Hospitalization; Required Intervention