MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-25 for BANTAM MEDIUM Y5500 manufactured by Altimate Medical, Inc..
[16550845]
One of our independent reps contacted ami and stated that while he was adjusting the seat depth adjustment on the bantam medium that the back moves freely once the knobs are loosened and that back hit him in the forehead causing a small cut in his forehead.
Patient Sequence No: 1, Text Type: D, B5
[16714297]
The bantam medium instructions for use includes instructions to support the back when adjusting the seat depth. The representative did not consult the instructions for use prior to adjusting the seat depth. Although this is covered in the instructions for use, altimate medical is adding a label on the back of the unit stating to support the back when adjusting seat depth as an additional preventive measure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183634-2013-00004 |
| MDR Report Key | 3452863 |
| Report Source | 07 |
| Date Received | 2013-10-25 |
| Date of Report | 2013-10-08 |
| Date of Event | 2013-10-08 |
| Date Mfgr Received | 2013-10-08 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-12-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STACEY FRANK |
| Manufacturer Street | 262 WEST FIRST STREET |
| Manufacturer City | MORTON MN 56270 |
| Manufacturer Country | US |
| Manufacturer Postal | 56270 |
| Manufacturer Phone | 5076976393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BANTAM MEDIUM |
| Generic Name | 890.3110 |
| Product Code | ION |
| Date Received | 2013-10-25 |
| Model Number | BANTAM MEDIUM |
| Catalog Number | Y5500 |
| Lot Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTIMATE MEDICAL, INC. |
| Manufacturer Address | 262 WEST FIRST ST. MORTON MN 56270 US 56270 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-25 |