Medline Industries, Inc. DYNJ34432IRecalls & reported problems
Medline Industries, Inc. · D&C · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489224696), received between Nov 20, 2020 and Nov 20, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
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.
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Entrapment of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2020Detachment of Device or Device Component
IT WAS REPORTED; THE SPONGE HAD DETACHED FROM THE STICK AND REMAINED IN THE VAGINA AFTER PREPPING THE PATIENT FOR SURGERY. THE NURSE HAD TO REMOVE THE SPONGE PORTION OF THE SPONGE STICK PRIOR TO THE START OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10876552 ↗MalfunctionNov 20, 2020Entrapment of Device; Detachment of Device or Device Component
IT WAS REPORTED; THE SPONGE HAD DETACHED FROM THE STICK AND REMAINED IN THE VAGINA AFTER PREPPING THE PATIENT FOR SURGERY. THE SURGEON HAD TO REMOVE THE SPONGE PORTION OF THE SPONGE STICK PRIOR TO THE START OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10876336 ↗MalfunctionNov 20, 2020Entrapment of Device; Detachment of Device or Device Component
IT WAS REPORTED; THE SPONGE HAD DETACHED FROM THE STICK AND REMAINED IN THE VAGINA AFTER PREPPING THE PATIENT FOR SURGERY. THE SURGEON HAD TO REMOVE THE SPONGE PORTION OF THE SPONGE STICK PRIOR TO THE START OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10876107 ↗
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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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