MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-05 for PHILIPS * manufactured by Philips.
[376522]
Rptr had a neck injury with cervical disc-c4-c5 herniation with spinal cord compression while moving a poorly designed protective lead shield at work designed by philips. Reporter has tried conservative therapy but reporter still has significant pain. Reporter is working but with restrictions. Reporter probably will have neck surgery in feburary of 2005 which may lead to significant short and long term complications and possible disability at a young age.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034310 |
| MDR Report Key | 566018 |
| Date Received | 2005-01-06 |
| Date of Report | 2005-01-05 |
| Date of Event | 2003-10-31 |
| Date Added to Maude | 2005-01-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS |
| Generic Name | PROTECTIVE LEAD SHIELD |
| Product Code | KPY |
| Date Received | 2005-01-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555805 |
| Manufacturer | PHILIPS |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2005-01-06 |