MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for HOVERMATT AIR TRANSFER SYSTEM manufactured by Hovertech International.
[145252752]
During surgical procedure, patient was secured onto operating room table with appropriate straps on the lower part of the body. Patient was also on a hover mat. The operating room table required tilting slightly to the left. Due to the slipperiness of the hovermatt, the patient slip/slid from the operating room table, resulting in hitting his left shoulder and left side of forehead on the floor, sustaining mild abrasions. No other injuries occurred. Pt was returned to the operating room table.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8615460 |
| MDR Report Key | 8615460 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-02-12 |
| Report Date | 2019-05-03 |
| Date Reported to FDA | 2019-05-03 |
| Date Reported to Mfgr | 2019-05-16 |
| Date Added to Maude | 2019-05-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOVERMATT AIR TRANSFER SYSTEM |
| Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
| Product Code | FRZ |
| Date Received | 2019-05-16 |
| Model Number | HOVERMATT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOVERTECH INTERNATIONAL |
| Manufacturer Address | 4482 INNOVATION WAY ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |