Medical Action Industries 56214Recalls & reported problems
Medical Action Industries Inc. · Class 1
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 10809160003763), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2021Use of Device Problem; Use of Device Problem
MAI COMPLAINT NUMBER - (B)(4). BEFORE PERFORMING A PROCEDURE ON A PATIENT, THE HEALTH CARE PROVIDER HAD TO USE EXTREME EXCESSIVE FORCE TO REMOVE THE PLASTIC COVERING OF BLADE AND WAS CUT IN THE LEFT HAND WHEN TRYING TO REMOVE THIS COVERING. PER THE CUSTOMER, "PROVIDER WILL NEED 48 HOUR WOUND CHECK, AFTER RECEIVING # 5 SUTURES (B)(6) 2020, DAY OF RECEIVING LACERATION INJURY FROM DESCRIBED INCIDENT, ABOVE, AND SAID PROVIDER WILL NEED SUTURES REMOVED 9-11 DAYS AFTER SUTURES APPLIED. PROVIDER MADE INCIDENT REPORT TO (B)(6) ON DAY OF INJURY, (B)(6) 2020. THE SCALPEL THAT I WAS CUT BY, AFTER EXCESSIVE FORCE REMOVING THE "POINT PROTECTOR", IS ON THE LEFT. THE PLASTIC COVER IS 3 NOTCHES DOWN, COVERING THE HANDLE, VERSUS THE OTHER SCALPEL IS NOT DOWN AS FAR, AND JUST COVERING HANDLE FLAT AREA." NO PATIENT INVOLVEMENT. HIBC/GTIN OF PRODUCT: (B)(4).
Patient problems: Injury
MAUDE report 11158175 ↗
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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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