MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-17 for NEPTUNE RECLINING BATH LIFT manufactured by Mountway/street Limited.
[23683471]
Consumer reports that her husband suffered a skin abrasion after the reclining bath seat from neptune cracked and suggests that the products should note that surface can break down and cause injury. The neptune reclining bath lift was purchased from (b)(4) in 2009. This spring, my husband suffered damage to the skin on his bottom due to a ctack in the surface of the bath seat. This problem was reported to neptune, who said that this didn't happen, and to (b)(4), who said it was outside the warranty period. I'm still waiting for a call back from (b)(4) to hear if they'll participate in the purchase of a cover for our replacement seat to protect my husband's skin from this happening again. I think the product literature should include a warning that under certain circumstances the platic surface can break down and pinch or abrade the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055559 |
| MDR Report Key | 5018409 |
| Date Received | 2015-08-17 |
| Date of Report | 2015-08-17 |
| Date Added to Maude | 2015-08-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 0 |
| Brand Name | NEPTUNE RECLINING BATH LIFT |
| Generic Name | LIFE, PATIENT, AC POWERED |
| Product Code | FNG |
| Date Received | 2015-08-17 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOUNTWAY/STREET LIMITED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-17 |