MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2015-05-22 for SCALAMOBIL S35 manufactured by Alber Gmbh.
[5931029]
Information of the importer/customer: (b)(6) (importer fms) spoke with the mother who was operating the scala with her daughter ((b)(6)) being transported in the chair. The scalamobil s35 is mounted to a ki mobility cat 5 (16" wide) wheelchair). Amato (daughter - wheelchair user) and mom tumbled down the stairs. Both the mom and daughter received some bumps and bruises. According to the mom, she forgot to tighten the adjustment knobs on the handles and also forgot to remove the manual wheels from the wheelchair as advised in the user manual. The combination of the two resulted in the accident which caused the scala and chair to fall down the stairs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2015-00001 |
| MDR Report Key | 4802223 |
| Report Source | 04,08 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-20 |
| Date of Event | 2015-04-28 |
| Date Facility Aware | 2015-04-28 |
| Date Reported to Mfgr | 2015-04-29 |
| Date Mfgr Received | 2015-04-29 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-05-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOPH HAUSCHEL |
| Manufacturer Street | VOR DEM WEISSEN STEIN 21 |
| Manufacturer City | ALBSTADT D-72461 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-72461 |
| Manufacturer Phone | 43220061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALAMOBIL |
| Generic Name | STAIRCLIMBER |
| Product Code | ILK |
| Date Received | 2015-05-22 |
| Model Number | S35 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALBER GMBH |
| Manufacturer Address | GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-22 |