MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD APPOSE ULC; STAPLE, REMOVABLE (SKIN)

Model Number	8886803512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971); Local Reaction (2035); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545); Unintended Radiation Exposure (4565); Wound Odor (4866)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
According to the reporter, a patient underwent a cesarean section closed with a skin stapler, the patient developed a localized postoperative wound complication characterized by a slightly inflammatory, warm but painless necrotic area (5 cm) at the center of the surgical scar, along with a blister and the release of foul-smelling serosanguinous fluid following removal of two staples.The adverse event required surgical intervention under general anesthesia, including wide excision of necrotic tissue (2 cm margin) and debridement to healthy tissue, followed by triple antibiotic therapy, microbiology cultures were positive for streptococcus oralis/mitis and staphylococcus epidermidis.Subsequent monitoring showed persistent inflammation, elevated c-reactive protein (crp), and imaging findings of a small hydroaeric collection in the abdominal wall, leading to adjustment of antibiotic therapy and continued clinical observation, with involvement of the hospital hygiene service for infection analysis.
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: APPOSE ULC
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• 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: 24911482
• Report Number: 9612501-2026-01093
• Device Sequence Number: 18424914
• Product Code: GDT
• UDI-Device Identifier: 10884521104365
• UDI-Public: (01)10884521104365(17)301031(10)J5L3910LY
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K900486
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 8886803512
• Device Catalogue Number: 8886803512
• Device Lot Number: J5L3910LY
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 11/27/2025
• 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 Age: 34 YR
• Patient Sex: Female