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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. ASPEN BLADE PROTECTED SIZE 15 BLADE, SCALPEL

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HILL-ROM, INC. ASPEN BLADE PROTECTED SIZE 15 BLADE, SCALPEL Back to Search Results
Model Number 0507373915
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2018
Event Type  malfunction  
Event Description
Safety blade is packages in a sterile pack. It was noted before the blade was removed from the packaging that there was a clear, substance inside the sterile package. It was removed as soon as the scrub person noted it. So far, 7 other blades with the same lot number have been removed from the packs.
 
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Brand NameASPEN BLADE PROTECTED SIZE 15
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
HILL-ROM, INC.
1069 state route 46 east
batesville IN 47006
MDR Report Key8184008
MDR Text Key131004502
Report Number8184008
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0507373915
Device Catalogue Number373915
Device Lot Number0167188
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2018
Event Location Hospital
Date Report to Manufacturer12/20/2018
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

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