MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-08-12 for PRODIGY ADVANCE NA manufactured by Ge Lunar Corp..
[1107097]
It was reported that during the installation of the prodigy advance system a pt tripped and fell on the portion of the system that was in the hall. The pt was taken to the er where she received six stitches on her hand.
Patient Sequence No: 1, Text Type: D, B5
[8352757]
A review of the installation instructions was completed, and the instructions were found to be adequate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124823-2009-00028 |
| MDR Report Key | 1437566 |
| Report Source | 07 |
| Date Received | 2009-08-12 |
| Date of Report | 2009-07-17 |
| Date of Event | 2009-07-17 |
| Date Mfgr Received | 2009-07-17 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2009-08-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTHA KAMROW |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. MAIL CODE -W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE LUNAR CORP. |
| Manufacturer Street | 726 HEARTLAND TRAIL |
| Manufacturer City | MADISON WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODIGY ADVANCE |
| Product Code | KGI |
| Date Received | 2009-08-12 |
| Model Number | PRODIGY ADVANCE |
| Catalog Number | NA |
| Lot Number | PA+302760 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE LUNAR CORP. |
| Manufacturer Address | 726 HEARTLAND TRAIL MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-08-12 |