MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-09-25 for VITAL SIGNS? HEAD POSITIONER 8000HDP manufactured by Vyaire Medical.
[121704855]
Vyaire medical complaint # (b)(4). Any additional information provided by the customer will be included in a follow up report. The device sample or was not available for investigation by our quality team. If additional information becomes available, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[121704856]
It was reported to vyaire that a patient suffered grade 3 bruising to the head while using the head positioner. The patient was in a prone position for 7 to 8 hours. The customer confirmed that medical intervention was required and additionally the patient required plastic surgery post complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00014 |
| MDR Report Key | 7907410 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-25 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-09-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | PRODUCTOS UR |
| Manufacturer Street | CERRADA V #85 PARQUE UNDUSTRAL MEXICALI |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS? HEAD POSITIONER |
| Generic Name | PRONE HEAD POSITIONER WITH MIRROR |
| Product Code | HBM |
| Date Received | 2018-09-25 |
| Model Number | HEAD POSITIONER |
| Catalog Number | 8000HDP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-25 |