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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD PARKER BLADE SIZE15

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD PARKER BLADE SIZE15 Back to Search Results
Model Number 373915
Device Problem Unintended Ejection (1234)
Patient Problem Injury (2348)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The tech was loading the blade onto the handle and it 'acted like it got caught' so the tech began applying force to try and apply the blade further when it forcefully ejected and ended up cutting the tech's finger.
 
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Brand NameBARD PARKER BLADE SIZE15
Type of DeviceBARD PARKER BLADE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer Contact
bradley liske
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key6680239
MDR Text Key79029979
Report Number1836161-2017-00067
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 06/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number373915
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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