MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-29 for PLAGIOCEPHY HELMET NI manufactured by *.
[16789513]
Rptr stated that dr at the referenced clinic has developed and is using a special helmet designed to correct plagiocephaly in the childrens ward of the hospital. Rptr also stated that the referenced device is not fda approved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003403 |
| MDR Report Key | 435446 |
| Date Received | 2002-10-29 |
| Date of Report | 2002-10-29 |
| Date Added to Maude | 2003-01-03 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | PLAGIOCEPHY HELMET |
| Generic Name | PLAGIOCEPHY HELMET |
| Product Code | NDA |
| Date Received | 2002-10-29 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 424371 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-10-29 |