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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES DRAPE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES DRAPE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 100773
Device Problems Defective Device (2588); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2013
Event Type  malfunction  
Event Description
It was reported that during setup of monitor drape, unpeeling the protective cover would cause the cover to tear as if stuck on the monitor interface material rendering the drape unusable as a sterile barrier. 4 out of 8 drapes had this problem. During procedure the functional drapes were used. There was no surgical delay reported.
 
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Brand NameDRAPE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd
suite 40
plymouth, mn
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, pa 
MDR Report Key9994115
MDR Text Key188842806
Report Number3010266064-2020-00110
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number100773
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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