MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-10-03 for LITHOSTAR MODULARIS 1158059 NA manufactured by Siemens Ag.
[526000]
While positioning a patient for a shockwave treatment, the patient grasped the table edge with his right hand. The attending physician reportedly moved the exam table transversely, and two of the patient's fingertips were severed. The patient was transferred to a hand surgery clinic and the severed fingertips were re-attached. The system's user manual provides clear warnings against possible danger points and also 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 | 2240869-2006-00013 |
| MDR Report Key | 767148 |
| Report Source | 01,07 |
| Date Received | 2006-10-03 |
| Date of Report | 2006-08-24 |
| Date of Event | 2006-07-21 |
| Date Mfgr Received | 2006-07-21 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-10-06 |
| 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 | ANN LADINO |
| Manufacturer Street | 51 VALLEY STREAM PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104481785 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | HENKESTRASSE 127 |
| Manufacturer City | ERLANGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOSTAR MODULARIS |
| Generic Name | TABLE, SYSTOMETRIC, ELECTRIC |
| Product Code | MMZ |
| Date Received | 2006-10-03 |
| Model Number | 1158059 |
| 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 | * |
| Device Sequence No | 1 |
| Device Event Key | 755048 |
| Manufacturer | SIEMENS AG |
| Manufacturer Address | HENKESTRASSE 127 ERLANGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-03 |