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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER DISPOSABLE SCALPELS SIZE 15, NON-STERILE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER DISPOSABLE SCALPELS SIZE 15, NON-STERILE Back to Search Results
Model Number 371633
Device Problem Break (1069)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported the physician was putting in a chest tube in a patient and the blade broke. The patient was injured and had to go to surgery to remove the blade.
 
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Brand NameBARD-PARKER DISPOSABLE SCALPELS SIZE 15, NON-STERILE
Type of DeviceBARD-PARKER DISPOSABLE SCALPELS 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
MDR Report Key6228282
MDR Text Key64511787
Report Number1836161-2017-00001
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 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371633
Device Lot Number0111051
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
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

Patient Treatment Data
Date Received: 01/06/2017 Patient Sequence Number: 1
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