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

Model Number	UL-102
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Pain (1994); Impaired Healing (2378); Swelling/ Edema (4577)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the patient underwent surgery to remove the preauricular cyst and nasolabial fold pigmented nevus.The device was used to reduce tension and prevent scars.After the suture was removed, the skin wound surface recovered well and was smooth without redness, swelling or ulceration.However, two weeks after the suture was removed, the intradermal suture was rejected, with local redness and swelling, white pus, exudation, pain, and the wound did not heal for a long time.The patient's wound was cleaned promptly.The patient came back for a follow-up visit to remove the intradermal suture, and the wound gradually healed, but it was still slightly red and swollen.
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: 22153650
• Report Number: 9612501-2025-01450
• Device Sequence Number: 9263101
• Product Code: GAM
• UDI-Device Identifier: 10884521049413
• UDI-Public: 10884521049413
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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: UL-102
• Device Catalogue Number: UL-102
• Device Lot Number: D3K4018Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/05/2025
• Date Device Manufactured: 10/23/2023
• 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
• Patient Age: 39 YR
• Patient Sex: Male