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

Model Number	SL-636
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	No Code Available (3191)
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, post operatively, the sutures broke.The wound had broken up and re-surgery had to be done.The suture was noted to break in about same place, in cutis, about 5-7cm from the stitch.The suture broke in the clinic.The knots has been left and suture has gone straight off.The cat was readmitted.
Additional Manufacturer Narrative
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: 7477703
• Report Number: 9612501-2018-00903
• Device Sequence Number: 1216422
• Product Code: GAM
• UDI-Device Identifier: 20884521049069
• UDI-Public: 20884521049069
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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 Model Number: SL-636
• Device Catalogue Number: SL-636
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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