MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-02-10 for EASYSTAND STRAPSTAND 200 manufactured by Altimate Medical, Inc..
[20119889]
On (b)(6) 2015 altimate medical (ami) customer service received an email from an independent rep requesting add'l edge covers and two bolt caps for an easystand strapstand at a facility in his territory. On (b)(6) 2015 a follow up call was made to the facility to find out more info. The facility contact stated that this is a nursing home with elderly clients and that their clients have very sensitive skin. They had a larger client transferring into the strapstand and he bumped the edges of the frame and received a skin tear on his elbow.
Patient Sequence No: 1, Text Type: D, B5
[20285556]
Because this strapstand is being used at a facility with an elderly population, altimate medical provided this facility with the add'l edging and bolt covers they requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183634-2015-00002 |
| MDR Report Key | 4510321 |
| Report Source | 06,07 |
| Date Received | 2015-02-10 |
| Date of Report | 2015-01-12 |
| Date of Event | 2015-01-12 |
| Date Mfgr Received | 2015-01-12 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-02-20 |
| 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 ST. |
| 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 | EASYSTAND STRAPSTAND |
| Generic Name | 890.5370 |
| Product Code | ION |
| Date Received | 2015-02-10 |
| Model Number | STRAPSTAND |
| Catalog Number | 200 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-02-10 |