MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88863001-72
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Abnormal Vaginal Discharge (2123); Unspecified Tissue Injury (4559)
Date of Event	12/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
According to literature source of study performed between october 2016 and august 2019, postoperative to transvaginal l uterosacral ligament suspension (usls) for apical vaginal prolapse, 23 women in the polyethylene terephthalate (pet) suture group experienced suture erosion.22 women had tissue granulation.Abnormal vaginal bleeding/discharge was also reported. these patients were initially treated with conservative therapy consisting of vaginal estrogen, antibiotics, policresulen solution or electrosurgery.All cases of suture erosion with or without granulation tissue did not resolve with conservative therapy and finally required excision in the office.
Additional Manufacturer Narrative
Title: suture complication rates and surgical outcomes according to the nonabsorbable suture materials used in vaginal uterosacral ligament suspension: polyester versus polypropylene source: journal of minimally invasive gynecology (2021) 28, 1503-1507 if information is provided in the future, a supplemental report will be issued.

• Brand Name: TI-CRON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12843834
• Report Number: 9612501-2021-01918
• Device Sequence Number: 19247992
• Product Code: GAT
• UDI-Device Identifier: 10884521058774
• UDI-Public: 10884521058774
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K930591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 88863001-72
• Device Catalogue Number: 88863001-72
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown