MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for HEIGHT MEASURING ROD manufactured by Unk.
[79984630]
Caller stated her back was against the wall, waiting to be measured, when the attached rod slammed down on her head. She sustained a concussion, traumatic brain injury, and spinal injury. The device was removed from the facility; (b)(6). Caller made a formal complaint at the attorney's office, and now two years later they are still utilizing the device in doctor's offices. Caller would like the device removed from all facilities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070930 |
| MDR Report Key | 6705858 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-07-11 |
| Date of Event | 2015-02-17 |
| Date Added to Maude | 2017-07-12 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEIGHT MEASURING ROD |
| Generic Name | HEIGHT MEASURING ROD |
| Product Code | FTY |
| Date Received | 2017-07-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-11 |