Medline Industries, Inc. DYNJ53752CRecalls & reported problems
Medline Industries, Inc. · DAVINCI PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327652012), received between Nov 13, 2025 and Nov 13, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
ACCORDING TO THE FACILITY, WHILE INTRA-OP, "A FOREIGN BODY WAS FOUND INSIDE THE ABDOMEN OF THE PATIENT. OBJECT IS BELIEVED TO BE A PIECE FROM THE MICROLINE SCISSOR TIP THAT COMES INSIDE THE PACK." PER THE FACILITY, "THE PIECE WAS IMMEDIATELY REMOVED, INTRAABDOMINAL INSPECTION WAS COMPLETED. ALL PARTS OF THE FOREIGN OBJECT WERE REMOVED." FACILITY REPORTS NO SERIOUS INJURY, MEDICAL INTERVENTION OR FOLLOW-UP CARE RELATED TO THE INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 23543265 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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