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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 Problem Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Samples of the aspen blades were sent by roi cps, llc to aspen surgical on 7/1/2020 after the initial complaints were received. Roi cps, llc requested that the manufacture of the blades perform an investigation and provide their corrective actions.
 
Event Description
Customer reported that every #10 blade with that lot number (0209336) was opened and compared with other blades was dull. The dull blades were contained within roi cps, llc custom pack (b)(4) open heart pack a&b and (b)(4) laminectomy pack.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE SURGICAL RIB BCK CARB 10
Manufacturer (Section D)
ASPEN SURGICAL
6945 south dr se
caledonia, mi
Manufacturer (Section G)
ASPEN SURGICAL
6945 southbelt dr se
caledonia, mi
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, mo 
7303937
MDR Report Key10465400
MDR Text Key219190508
Report Number3014527682-2020-00012
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 Administrator/Supervisor
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2020
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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