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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA SAFETY PIN 2 INCH STERILE
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ASPEN SURGICAL PRODUCTS, CALEDONIA SAFETY PIN 2 INCH STERILE Back to Search Results
Model Number 2203
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the product at this time.The investigation is ongoing.However if any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.Device not returned.
 
Event Description
Aspen surgical received a report from the distributor indicating that the product was found with a seal issue.Item was not in use.Reported issue was filed under our complaint handling system under number (b)(4).
 
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Brand Name
SAFETY PIN 2 INCH STERILE
Type of Device
SAFETY PIN
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 Key12916430
MDR Text Key283104740
Report Number1836161-2021-00045
Device Sequence Number1
Product Code KDC
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2203
Device Lot Number262373
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/04/2021
Initial Date FDA Received12/02/2021
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
Patient Sequence Number1
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