MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for UNKNOWN NP1965 manufactured by Mizuho America, Inc..
[100464886]
Patient Sequence No: 1, Text Type: N, H10
[100464887]
Device was in place with pins holding the patient's head. The supporting screw broke and provider supported patient's head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7281950 |
| MDR Report Key | 7281950 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-08 |
| Date of Event | 2018-02-03 |
| Report Date | 2018-02-08 |
| Date Reported to FDA | 2018-02-08 |
| Date Reported to Mfgr | 2018-02-08 |
| Date Added to Maude | 2018-02-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | HEADREST, NEUROSURGICAL |
| Product Code | HBM |
| Date Received | 2018-02-20 |
| Model Number | NP1965 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO AMERICA, INC. |
| Manufacturer Address | 30057 AHERN AVE. UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-20 |