MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-26 for STANNAH 260 manufactured by .
[5928309]
The consumer stated that shortly after the chair lift was installed (date unk) the consumer saw that silicone oil was spewing from the chain which is not covered. The consumer contacted the company. The consumer stated that mr. (b)(4) and his son came back out and advised the consumer that it was only dust. The chair is also jerking as it comes around the corner at the bottom stairs and scratching the pipes. Also, the material on the foot pad is shredding. The consumer stated that the last time the company sent someone else, the son was using (b)(6) to clean the oil. Retailer: (b)(4). The prod was not damaged before the incident. The prod was not modified before the incident. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5042886 |
MDR Report Key | 4814860 |
Date Received | 2015-05-26 |
Date of Report | 2015-05-18 |
Date of Event | 2014-02-01 |
Date Added to Maude | 2015-06-04 |
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 | 0 |
Health Professional | 0 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | STANNAH |
Generic Name | CHAIR LIFT |
Product Code | IPL |
Date Received | 2015-05-26 |
Model Number | 260 |
Device Availability | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2015-05-26 |