MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-01-05 for HOVERMATT LATERAL PATIENT TRANSFER DEVICE HM34SPU manufactured by D.t. Davis Enterprises Ltd. T/a Hovertech International.
[2574331]
Lpn in (b)(6) medical center burn unit transferring pt from stretcher to bed using hovermatt single pt use and 2 - 3 additional staff. Felt a minor shoulder pull (no pain) when she went to reach hovermatt handle. Later in the day became an ache, no lost time, no physical restrictions at 2 days post. Now has physical restrictions as of this date, (b)(6) 2011. Medical followed and treated by (b)(6) department.
Patient Sequence No: 1, Text Type: D, B5
[9768878]
(b)(6) stated in an e-mail: "i believe that the incident with the hovermatt was user error. I do not think it is a faulty equipment issue. " the device was not removed from service. Since the hovermatt was not the cause of the incident, it was not returned to hovertech international for evaluation. We have been in communication with facility and have arranged for a re-training session on january 17, 2912 at the facility. A sales representative from d. T. Davis will be leading the training and emphasizing the correct ergonomics of using the hovermatt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531468-2011-00003 |
| MDR Report Key | 2501425 |
| Report Source | 05,07 |
| Date Received | 2012-01-05 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-11-30 |
| Date Facility Aware | 2011-11-30 |
| Report Date | 2011-01-04 |
| Date Mfgr Received | 2011-12-06 |
| Date Added to Maude | 2012-07-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN PAVELKO |
| Manufacturer Street | 513 S. CLEWELL ST. |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 8004712776 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOVERMATT LATERAL PATIENT TRANSFER DEVICE |
| Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
| Product Code | FRZ |
| Date Received | 2012-01-05 |
| Model Number | HM34SPU |
| Catalog Number | HM34SPU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL |
| Manufacturer Address | 513 S. CLEWELL ST. BETHLEHEM PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-01-05 |