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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 FERGUSON, REG EYE, .050X2.480, STERILE SURGICAL NEEDLE

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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER FERGUSON, REG EYE, .050X2.480, STERILE SURGICAL NEEDLE Back to Search Results
Model Number 209504
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/01/2020
Event Type  Injury  
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. Other text : device not returned.
 
Event Description
Aspen surgical received a medwatch report (uf/importer report (b)(4)) indicating that during surgery the tip of a needle broke off. Incident occurred at the end user. This event was filed in our complaint handling system as number (b)(4).
 
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Brand NameNEEDLE 1/2 CIRCLE TAPER FERGUSON, REG EYE, .050X2.480, 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 Key9903038
MDR Text Key185776318
Report Number1836161-2020-00018
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 faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number209504
Device Lot Number177096
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/03/2020
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 Treatment Data
Date Received: 03/31/2020 Patient Sequence Number: 1
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