MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-02 for DOC BAND NI manufactured by Cranial Therapies, Inc..
[84231]
The rptr's call was prompted by an advertisement she saw in a magazine. The rptr is not calling in an official capacity. While at a conference in los angeles, the rptr saw the advertisement for doc band in a local parent's magazine. The rptr had concerns as to safety of the device in relation to its intended use. The advertised use is for correcting the misshapen heads of children.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013901 |
| MDR Report Key | 170694 |
| Date Received | 1998-06-02 |
| Date of Report | 1998-06-02 |
| Date Added to Maude | 1998-06-04 |
| 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 | ATTORNEY |
| 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 | DOC BAND |
| Generic Name | CRANIOPLASTY |
| Product Code | IQF |
| Date Received | 1998-06-02 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | NOT APPLICABLE |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 166034 |
| Manufacturer | CRANIAL THERAPIES, INC. |
| Manufacturer Address | 1023 N. HOLLYWOOD WAY STE. 103 BURBANK CA 915052539 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-06-02 |