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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE
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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE Back to Search Results
Model Number 371115
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2015
Event Type  malfunction  
Event Description
The customer stated: they had issues with the blades being difficult to fit onto the scalpel handles and almost impossible to get off the handles.Some blades have broken and some developed dark spots during use.This was reported on the plastic pack.Neither patient injury nor medical intervention has been reported.
 
Event Description
The customer stated: they had issues with the blades being difficult to fit onto the scalpel handles and almost impossible to get off the handles.Some blades have broken and some developed dark spots during use.This was reported on the plastic pack.Neither patient injury nor medical intervention has been reported.
 
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Brand Name
BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE
Type of Device
BARD-PARKER CARBON RIB-BACK BLADES SIZE 15
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
6166987100
MDR Report Key5221358
MDR Text Key31333174
Report Number1836161-2015-00089
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 distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number371115
Device Lot Number0073470
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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