MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-11 for LITHOSTAR MODULARIS 5531012 NA manufactured by Siemens Medical Solutions Usa, Inc..
[383350]
During a procedure, a pt used the frame of the examination table as a hand grip. When the examination table was moved by the operator, the patient's fingers were reportedly injured, resulting in two broken fingers, the user's maunal clearly warns against possible danger points and states that no part of the patient's body may project beyond the tabletop during an examination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2240869-2005-00003 |
| MDR Report Key | 572815 |
| Date Received | 2005-02-11 |
| Date of Report | 2005-02-04 |
| Date of Event | 2004-10-11 |
| Date Mfgr Received | 2005-01-05 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2005-02-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CATHERINE MOFFA |
| Manufacturer Street | 51 VALLEY STREAM PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104481774 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | WITTELSBACHERPLATZ 2 |
| Manufacturer City | MUNCHEN D-80333 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-80333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOSTAR MODULARIS |
| Generic Name | UROLOGICAL TABLE |
| Product Code | MMZ |
| Date Received | 2005-02-11 |
| Model Number | 5531012 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 562683 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PKWY. MALVERN PA 19355 US |
| Baseline Brand Name | LITHOSTAR MODULARIS |
| Baseline Generic Name | UROLOGICAL TABLE |
| Baseline Model No | 5531012 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-11 |