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

Model Number	CM-812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
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, after a spaying procedure on a veterinary case, on the 12th post-operative day, patient was sent to the emergency hospital as omentum was herniated.On exploratory at the central portion, they reported that suture material was snapped at the mid incision.Patient undergone surgical repair.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of two devices.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after a spaying procedure on a veterinary case, on the 12th post-operative day, patient was sent to the emergency hospital as omentum was herniated.On exploratory at the central portion, they reported that suture material was snapped at the mid incision while doing a simple continuous stitch.Patient undergone surgical repair that led to extended hospital stay.There was reported tissue damage and extended incision.

• Brand Name: BIOSYN
• 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: 8325696
• Report Number: 9612501-2019-00215
• Device Sequence Number: 2138675
• Product Code: GAM
• UDI-Device Identifier: 10884521031937
• UDI-Public: 10884521031937
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 07/31/2022
• Device Model Number: CM-812
• Device Catalogue Number: CM-812
• Device Lot Number: D7G1984X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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
• Patient Weight: 27