CONVERTORS 39099Recalls & reported problems
Cardinal Health 200, LLC · SmartGown Surgical Gown, 3XL, Long · Class 2
Data updated Oct 13, 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 10192253010473), received between Jan 3, 2021 and Jan 3, 2021 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2021Adverse Event Without Identified Device or Use Problem
BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THEY ALLEGEDLY HAD AN ADVERSE REACTION TO GOWN 39099. PER CUSTOMER THE EVENT DATE WAS SOMETIME BETWEEN (B)(6) 2020, NOT AWARE OF REACTION UNTIL DAYS LATER. THEY WERE SEEN IN EMPLOYEE HEALTH, DERMATOLOGIST AND ALLERGIST. THEY WERE REPORTEDLY PRESCRIBED TOPICAL BETAMETHASONE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11105782 ↗
Other GOWN, SURGICAL devices
- Medline DYNJP2001SMedline Industries, Inc. · GOWN, SURGICAL2 recalls9 reports
- Medline DYNJP2202SMedline Industries, Inc. · GOWN, SURGICAL2 recalls5 reports
- MEDLINE DYNJP2002SMedline Industries, Inc. · GOWN, SURGICAL2 recalls4 reports
- Medline DYNJP2602Medline Industries, Inc. · GOWN, SURGICAL2 recalls3 reports
- Medline Industries, Inc. DYNJP2402Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- MEDLINE DYNJP2002Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- Medline DYNJP2103Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
- Medline DYNJP2203Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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