MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-30 for SUGITA 07-954-00 manufactured by Mizuho.
[17390490]
Sugita scalp hook broke off in pt during use. Dates of use: (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037558 |
| MDR Report Key | 3977525 |
| Date Received | 2014-07-30 |
| Date of Report | 2014-07-29 |
| Date of Event | 2014-07-28 |
| Date Added to Maude | 2014-08-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUGITA |
| Generic Name | SUGITA SCALP HOOK |
| Product Code | HBO |
| Date Received | 2014-07-30 |
| Catalog Number | 07-954-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO |
| Manufacturer Address | UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-30 |