MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-29 for RIFTON HTS Z120 manufactured by Rifton Equipment.
[112804587]
From the details we know of the incident it seems likely that the caregiver had not fully engaged the seat hooks into the mounting bar. The user reported that the right hook was bent, and pictures submitted by the caregiver show that the seat fell off the right side of the toilet. This suggests that the left hook was not engaged with the mounting bar allowing the seat to pivot to the right, deforming the right hook, breaking the right side of the mounting bar, and allowing the seat to fall off the right side of the toilet. The product manual and product labeling warns that the seat hooks must be fully engaged in the mounting bar. In addition, the report from the user suggests that she was not supervising the client at the time of the incident. The product manual warns that adult supervision is required at all times.
Patient Sequence No: 1, Text Type: N, H10
[112804588]
It was reported that the client was using the rifton toilet seat mounted to a toilet using the mounting bar. One end of the mounting bar broke, and the toilet seat and the client fell sideways off the toilet. The client received a concussion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010761454-2018-00002 |
| MDR Report Key | 7652757 |
| Report Source | CONSUMER |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-14 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2015-09-29 |
| Date Added to Maude | 2018-06-29 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TRAVIS SCOTT |
| Manufacturer Street | 103 WOODCREST DRIVE |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal | 12471 |
| Manufacturer Phone | 8456587722 |
| Manufacturer G1 | RIFTON EQUIPMENT |
| Manufacturer Street | 100 SPRING VALLEY ROAD |
| Manufacturer City | FARMINGTON PA 15437 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIFTON HTS |
| Generic Name | TOILET CHAIR |
| Product Code | INN |
| Date Received | 2018-06-29 |
| Model Number | Z120 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | 103 WOODCREST DRIVE RIFTON NY 12471 US 12471 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-29 |