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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.260 STERILE SURGICAL NEEDLE

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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.260 STERILE SURGICAL NEEDLE Back to Search Results
Model Number 216704
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2020
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 following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Aspen surgical received a report from the end user indicating that a needle broke during a procedure. No injury or death was reported. The report was filed in our complaint handling system as number (b)(4).
 
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Brand NameNEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.260 STERILE
Type of DeviceSURGICAL NEEDLE
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 Key10661517
MDR Text Key214598059
Report Number1836161-2020-00049
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number216704
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/15/2020
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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