MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-01 for SCALACOMBI S36 manufactured by Alber Gmbh.
[76447451]
Device returned to manufacturer, no malfunction found.
Patient Sequence No: 1, Text Type: N, H10
[76447452]
While the wife was using the scalacombi s36 to transport her husband down the stairs, the device allegedly tilted sideways to the wall causing her husband to hit his head. The husband was admitted to the hospital for head injury and lacerations. The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[83751198]
Core id:ci1496342818518. 13364574@fdsuv08638_te1, batch id: 3004730072-20170601144658, date entered: thu jun 01 14:53:14 edt 2017, was entered in error. The same information can be found in: core id:ci1495036931479. 20286355@fdsuv08637_te1, batch id: 3004730072-20170517120211, date entered: wed may 17 12:10:39 edt 2017, summary: passed:1, failed:0.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004730072-2017-00005 |
| MDR Report Key | 6605704 |
| Report Source | CONSUMER |
| Date Received | 2017-06-01 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2014-06-27 |
| Date Added to Maude | 2017-06-01 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | ALBER GMBH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALACOMBI S36 |
| Generic Name | ELEVATOR |
| Product Code | ING |
| Date Received | 2017-06-01 |
| Model Number | S36 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALBER GMBH |
| Manufacturer Address | VOR DEM WEISSEN STEIN 21, ALBSTADT, GERMANY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-06-01 |