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U.S. Department of Health and Human Services

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

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ASPEN SURGICAL BARD-PARKER BLADE SURGICAL RIB BCK CARB 10 Back to Search Results
Model Number 371110
Device Problems Dull, Blunt (2407); Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2020
Event Type  malfunction  
Event Description
Physician complained that the surgical blade in c-section pack was dull, would not cut through the patient's skin. This occurred eight different times. Patient contact and the procedure was delayed to retrieve new blades from the store room.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE SURGICAL RIB BCK CARB 10
Manufacturer (Section D)
ASPEN SURGICAL
caledonia, mi
Manufacturer (Section G)
ROI CPS, LLC
3000 east sawyer road
republic, mo
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, mo 
7303937
MDR Report Key10258219
MDR Text Key206188938
Report Number3014527682-2020-00007
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 health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2020
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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