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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 3/8 CIRCLE REVERSE CUTTING, .027X.827, STERILE SURGICAL NEEDLE

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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 3/8 CIRCLE REVERSE CUTTING, .027X.827, STERILE SURGICAL NEEDLE Back to Search Results
Model Number 209020
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/10/2020
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.
 
Event Description
Aspen surgical received a report from the distributor indicating that a needle broke during a procedure. Incident occurred at the end user. This event was filed in our complaint handling system as number c-1180872.
 
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Brand NameNEEDLE 3/8 CIRCLE REVERSE CUTTING, .027X.827, 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 Key10373600
MDR Text Key202007644
Report Number1836161-2020-00037
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 distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number209020
Device Lot Number138772
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/10/2020
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

Patient Treatment Data
Date Received: 08/06/2020 Patient Sequence Number: 1
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