MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2009-05-18 for MAYFIELD SWIVEL HORSESHOE HEADREST A1012 manufactured by .
[1259712]
Reporter stated, the product slips with the pt in the holder. No injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8314702]
To date, the device involved in the reported incident has been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2009-00023 |
| MDR Report Key | 1461433 |
| Report Source | 04,06 |
| Date Received | 2009-05-18 |
| Date of Report | 2009-05-18 |
| Date Facility Aware | 2009-04-20 |
| Date Added to Maude | 2009-11-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHANNON DAVID |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYFIELD SWIVEL HORSESHOE HEADREST |
| Generic Name | NA |
| Product Code | HBM |
| Date Received | 2009-05-18 |
| Catalog Number | A1012 |
| Lot Number | 977 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-18 |