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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 SUTURE NEEDLES

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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT SUTURE NEEDLES Back to Search Results
Model Number 216706
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2017
Event Type  malfunction  
Event Description
Doctor (b)(6) was performing shoulder procedures when 4 needles broke on monday (b)(6). The patient and the procedure was not affected. The needles were thrown away.
 
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Brand NameNEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT
Type of DeviceSUTURE NEEDLES
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer Contact
megan morrissey
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key6667888
MDR Text Key78566191
Report Number1836161-2017-00065
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 06/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number216706
Device Lot Number108419
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2017
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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