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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 11, STERILE BARD PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE BARD PARKER BLADE Back to Search Results
Model Number 371111
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
We were notified of a complaint from a customer stated when making an initial incision the blade broke. The tip of the broken blade floated into the knee joint and was retrieved. It is unknown how the blade was removed or if this caused a delay in the procedure. Device was received and complaint confirmed. Due to the reported incident and in an abundance of caution, an mdr is being filed and the reference number is (b)(4).
 
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Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE
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 Key6552928
MDR Text Key74832992
Report Number1836161-2017-00042
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
Type of Report Initial
Report Date 04/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371111
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Yes
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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