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

Model Number	GL-34-MG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Low Oxygen Saturation (2477); Swelling/ Edema (4577)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, postoperatively of a laparoscopic gastric malignant tumor surgery, the patient's general condition was good after surgery and the adverse event was not device related.After the patient moved, the abdominal drainage drained bloody fluid, and the amount of drainage fluid increased significantly.The hemoglobin of the blood routine examination continued to decrease.Also, the abdominal ct scan showed peritoneal hemorrhage, and delayed abdominal hemorrhage was considered.It was also reported that the laparoscopic peritoneal hemorrhage removal was performed under general anesthesia from (b)(6) 2024 19:35 to (b)(6) 2024: 40; abdominal hemostasis after recent laparotomy.During the procedure, blood clots and free blood accumulation were found in the abdominal and pelvic cavities, with a total amount of about 500ml.The blood clots were mainly located in the left upper abdomen and pelvic cavity, and dark red blood and a small amount of blood clots were seen around the spleen.The mesangial tear was seen at the wound edge of the mesangial fissure suture, with local blood oozing and obvious tissue edema.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20613277
• Report Number: 9612501-2024-02801
• Device Sequence Number: 8821089
• Product Code: GAM
• UDI-Device Identifier: 10884521045316
• UDI-Public: 10884521045316
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: GL-34-MG
• Device Catalogue Number: GL-34-MG
• Device Lot Number: D3L3660Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/05/2024
• Date Device Manufactured: 11/17/2023
• 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; Life Threatening
• Patient Sex: Male