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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COBAN ; BANDAGE, ELASTIC
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COBAN ; BANDAGE, ELASTIC Back to Search Results
Catalog Number CAH45LFS
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2019
Event Type  malfunction  
Event Description
Roll of coban 4 x 5 yards that tears so easily that they cannot use it.Lot lf180924-sh, cat #cah45lfs.
 
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Brand Name
COBAN
Type of Device
BANDAGE, ELASTIC
MDR Report Key8795248
MDR Text Key151569875
Report NumberMW5088187
Device Sequence Number1
Product Code FQM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCAH45LFS
Device Lot NumberLF180924-SH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2019
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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