MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-28 for HOVERMATT manufactured by D.t. Davis Enterprises.
[29749075]
Patient Sequence No: 1, Text Type: N, H10
[29749076]
Hovermatt was in place on the operating room table when the patient was placed in lithotomy position, prepped, and draped for surgical procedure. When the table was placed in trendelenburg, there was an observed slippage towards the head of the table. The plastic material component of the hovermatt was thought to be the cause of the slippage. The hovermatt had to be removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5183053 |
| MDR Report Key | 5183053 |
| Date Received | 2015-10-28 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-04-18 |
| Report Date | 2015-09-29 |
| Date Reported to FDA | 2015-09-29 |
| Date Reported to Mfgr | 2015-09-29 |
| Date Added to Maude | 2015-10-28 |
| 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 | HOVERMATT |
| Generic Name | DEVICE, PATIENT TRANSFER |
| Product Code | FRZ |
| Date Received | 2015-10-28 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIS ENTERPRISES |
| Manufacturer Address | 513 S CLEWELL STREET FOUNTAIN HILL PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-28 |