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U.S. Department of Health and Human Services

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

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ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK BARB 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  
Event Description
Discovered during procedure, no delay to case, no harm to patient, but there was patient contact. Blades were dull in custom packs. The dull blades were contained within roi cps, llc custom pack 880151009 (surgi start) lot numbers 2003543811 and 2002944022.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE SURG RIB BCK BARB 10
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt 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 Key10521351
MDR Text Key231189370
Report Number3014527682-2020-00013
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 user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371110
Device Catalogue Number371110
Device Lot Number0209336 AND 0209798
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 Received08/07/2020
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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