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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CALDERA MEDICAL, INC. T-SLING SURGICAL MESH

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CALDERA MEDICAL, INC. T-SLING SURGICAL MESH Back to Search Results
Model Number CAL-TS05
Device Problem Material Erosion (1214)
Patient Problem Incontinence (1928)
Event Date 09/15/2009
Event Type  Injury  
Event Description
Reported by attorney: pt claims to continue to suffer dyspareunia, urinary incontinence, severe pain including abdominal pain, back pain, pain during intercourse, emotional stress.
 
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Brand NameT-SLING
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
CALDERA MEDICAL, INC.
5171 clareton dr
agoura hills CA 91301
MDR Report Key2629720
MDR Text Key21988562
Report Number3003990090-2012-00028
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation
Type of Report Initial
Report Date 06/08/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAL-TS05
Device Lot Number0431
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/08/2012
Distributor Facility Aware Date05/11/2012
Event Location Hospital
Date Report to Manufacturer06/08/2012
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 06/13/2012 Patient Sequence Number: 1
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