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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371210-150
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
Event Type  malfunction  
Event Description
Aspen surgical received a report indicating that the product was found with a seal issue. The item was not in use. No injury or adverse event was reported. The reported issue was filed under our complaint handling system under number (b)(4).
 
Manufacturer Narrative
No further information is available on the product at this time. The device was not returned for evaluation. However if any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report. Device not returned.
 
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Brand NameBARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE
Type of DeviceBARD-PARKER BLADE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
jordan hackert
6945 southbelt dr. s.e.
caledonia, MI 49316
6165367508
MDR Report Key12962783
MDR Text Key283477495
Report Number1836161-2021-00046
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371210-150
Device Lot Number0024538
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/10/2021
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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