MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MCKESSON; SUTURE, ABSORBABLE, NATURAL

Model Number	S687G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, on (b)(6) 2025, 5 days after the lower blepharoplasty procedure, the patient's eyes were very swollen.It was observed that the body was rejecting the suture causing the eyelid to swell, blister, water and sag.The patient was given steroid and antibiotic drops which appear to be helping but very slowly.
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.
Additional Manufacturer Narrative
Correction: e1 (fax number) additional information: d9, g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that on (b)(6) 2025, 5 days after the lower blepharoplasty procedure, the patient's eyes were noted to be very swollen.It was observed that the body was rejecting the suture causing the eyelid to swell, blister, water and sag.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: MCKESSON
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24084985
• Report Number: 9612501-2026-00111
• Device Sequence Number: 13235445
• Product Code: GAL
• UDI-Device Identifier: 10612479213118
• UDI-Public: (01)10612479213118(17)291031(10)D4L3593FZY
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: S687G
• Device Catalogue Number: S687G
• Device Lot Number: D4L3593FZY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 65 KG