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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL, STERILE

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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL, STERILE Back to Search Results
Model Number 213404
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported that needle broke when surgeon was using it. The item was in use at the time of the alleged malfunction, no injury occurred.
 
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Brand NameNEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL, STERILE
Type of DeviceNEEDLE
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 Key6499688
MDR Text Key73332644
Report Number1836161-2017-00031
Device Sequence Number1
Product Code GAB
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 03/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number213404
Device Lot Number117242
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2017
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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