• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CALDERA MEDICAL, INC. T-SLING SURGICAL MESH Back to Search Results
Model Number CAL-TS05
Device Problem Material Erosion
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameT-SLING
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
CALDERA MEDICAL, INC.
5171 clareton dr
agoura hills CA 91301
MDR Report Key2629720
Report Number3003990090-2012-00028
Device Sequence Number1
Product CodeFTL
Report Source Distributor
Source Type Unknown
Reporter Occupation NOT APPLICABLE
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 HEALTH PROFESSIONAL
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
-
-