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

Model Number	8886627761
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Hemorrhage/Blood Loss/Bleeding (1888); Swelling (2091); Hernia (2240); Discomfort (2330); No Code Available (3191)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(surgical intervention required) if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post operatively, the patient had hernia spray repair.The skin along the original wound was opened.The muscle layer was completely open due to the device knot untying at end.The edge of the muscle layer was freshened and skin edges.Skin closure was performed and medication was provided.After 10 days, the stitches were removed, the cranial end of wound was very sore and bleeding a little.
Additional Manufacturer Narrative
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: 7765093
• Report Number: 9612501-2018-01432
• Device Sequence Number: 1981166
• Product Code: GAM
• UDI-Device Identifier: 10884523002751
• UDI-Public: 10884523002751
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 04/30/2022
• Device Model Number: 8886627761
• Device Catalogue Number: 8886627761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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
• Patient Age: 6 MO