MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-16 for S35 SCALAMOBLIE NA:S35 manufactured by Alber Gmbh.
[127353627]
This event occurred in (b)(6), invacare is filing this report because the device is also marketed and sold in the u. S. The product has not been returned, therefore an investigation has not been completed. When additional information becomes available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[127353628]
This event happened in (b)(6). While using the s35 scalamoblie to take the end user downstairs it suddenly fell. The end user suffered some bruises, and he broke his nose in two places. He was admitted to the hospital for two days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004730072-2018-00010 |
| MDR Report Key | 8077457 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-16 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2018-11-16 |
| 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 | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | ALBER GMBH |
| Manufacturer Street | VOR DEM WEISSEN |
| Manufacturer City | ALBSTADT 72461 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 72461 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S35 SCALAMOBLIE |
| Generic Name | ELEVATOR, WHEELCHAIR, PORTABLE |
| Product Code | ING |
| Date Received | 2018-11-16 |
| Model Number | NA:S35 |
| Catalog Number | S35 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALBER GMBH |
| Manufacturer Address | VOR DEM WEISSEN STEIN 21 ALBSTADT 72461 GM 72461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-16 |