MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-02-03 for DORNIER UROTRACT UT NA manufactured by Dornier Medtech America.
[443861]
Two bolts broke off the two bolts bent on tube arm connection to the table, during pt positioning. Customer was trying to move the pt and the tube arm came loose. No serious injuries reported during the event. However, there is a potential for a serious injury if the malfunction were to recur and all bolts were to fail, causing the tube arm to fall on someone, or potentially sharp edges exposed or electrical shock hazzard with the exposed wiring. A mdr will be filed, due to the "potential for serious injury".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037955-2006-00001 |
| MDR Report Key | 670495 |
| Report Source | 06 |
| Date Received | 2006-02-03 |
| Date of Report | 2006-02-03 |
| Date of Event | 2006-01-06 |
| Report Date | 2006-02-03 |
| Date Mfgr Received | 2006-01-16 |
| Device Manufacturer Date | 1994-02-01 |
| Date Added to Maude | 2006-02-03 |
| 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 | TIM THOMAS |
| Manufacturer Street | 1155 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7705146163 |
| Manufacturer G1 | DORNIER MEDTECH AMERICA INC. |
| Manufacturer Street | 1155 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER UROTRACT |
| Generic Name | UROLOGY TABLE |
| Product Code | MMZ |
| Date Received | 2006-02-03 |
| Model Number | UT |
| Catalog Number | NA |
| Lot Number | UT3022 |
| 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 | 659805 |
| Manufacturer | DORNIER MEDTECH AMERICA |
| Manufacturer Address | * KENNESAW GA * US |
| Baseline Brand Name | DORNIER UROTRACT |
| Baseline Generic Name | UROLOGY TABLE |
| Baseline Model No | UT |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-02-03 |