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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK CARB 10

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ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK CARB 10 Back to Search Results
Model Number 371110
Device Problem Dull, Blunt (2407)
Patient Problem Insufficient Information (4580)
Event Date 10/14/2020
Event Type  malfunction  
Event Description
The 10 blade in packs were dull. Discovered during procedure, no delay to case, no harm to patient, but there was patient contact. The dull blades were contained within roi cps, llc custom pack (b)(4) (minor neuro) lot 79280ab.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE SURG RIB BCK CARB 10
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt dr se
caledonia MI 49316
Manufacturer (Section G)
ASPEN SURGICAL
6945 southbelt dr se
caledonia MI 49316
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, MO 65738
4177303937
MDR Report Key10733655
MDR Text Key214652561
Report Number3014527682-2020-00019
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 10/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371110
Device Lot Number0209336
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
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

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