3M™ Coban™ 1584SRecalls & reported problems
3m Company · 3M™ Coban™ Sterile Self-Adherent Wrap, 1584S, 4 in x 5 yd (10 cm x 4,5 m), 18 Rolls/Case · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00707387802295), received between Oct 19, 2022 and Dec 31, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequate User Interface” (2 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 16, 2026.
Most reported problems
Device problems
- Inadequate User Interface2
Patient problems
- Blister2
- Ulcer1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 2022Inadequate User Interface; Inadequate User Interface
A PATIENT ALLEGEDLY EXPERIENCED POSTOPERATIVE ULCERATION WITH THE USE OF 3M¿ COBAN¿ SELF-ADHERENT WRAP 1584L, LOT 103923302. THE LARGEST BLISTER WAS REPORTEDLY 4CM X 5CM, AND THE WOUND WAS SUBSEQUENTLY DISINFECTED WITH IODINE. NO MEDICAL INTERVENTIONS WERE REPORTED.
Patient problems: Blister; Ulcer
MAUDE report 16081289 ↗InjuryOct 19, 2022Inadequate User Interface; Inadequate User Interface
A 58-YEAR-OLD MALE ALLEGEDLY EXPERIENCED SEVERE BLISTERING WITHIN 24 HOURS POST APPLICATION OF A 3M¿ COBAN¿ SELF-ADHERENT WRAP, 1584, LOT 103731727. THE LARGEST BLISTER WAS REPORTEDLY 5CM X 9CM WITH WATER EXUDATION OBSERVED AT THE BANDAGE SITE. THE AREA WAS DISINFECTED WITH IODINE. NO MEDICAL INTERVENTIONS WERE REPORTED.
Patient problems: Blister
MAUDE report 15632459 ↗
Other BANDAGE, ELASTIC devices
- Surgitube® 241Derma Sciences Canada Inc · BANDAGE, ELASTIC1 recall0 reports
- Surgitube® 220Derma Sciences Canada Inc · BANDAGE, ELASTIC1 recall0 reports
- Surgitube® 219Derma Sciences Canada Inc · BANDAGE, ELASTIC1 recall0 reports
- Surgitube® 242Derma Sciences Canada Inc · BANDAGE, ELASTIC1 recall0 reports
- Surgitube® 222Derma Sciences Canada Inc · BANDAGE, ELASTIC1 recall0 reports
- Surgitube® 243Derma Sciences Canada Inc · BANDAGE, ELASTIC1 recall0 reports
- PROFORE KIT LATEX FREE 66020626Smith & Nephew Medical Limited · Bandage, Elastic45 reports
- PROFORE 18-25CM ANKLE CIRC. Case 8 66000016Smith & Nephew Medical Limited · Bandage, Elastic19 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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