MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-05-31 for EASYSTAND STRAPSTAND 2000 manufactured by Altimate Medical, Inc..
[3529826]
On (b)(4) 2013 altimate medical received a phone call from a medical equipment dealer requesting arm covers for their easystand strapstand due to a client getting a skin tear/cut when going from the standing to the sitting position. To obtain more information regarding how this occurred, altimate contacted the facility and was informed that this facility has elderly patients that are on coumadin and that their skin is very sensitive and can cut very easily. Because of this, the facility requested fabric covers to cover the metal on the arms of the easystand strapstand.
Patient Sequence No: 1, Text Type: D, B5
[10836240]
Altimate medical contacted the upholstery supplier and had fabric covers made for this particular facility per their request.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183634-2013-00002 |
| MDR Report Key | 3144974 |
| Report Source | 08 |
| Date Received | 2013-05-31 |
| Date of Report | 2013-05-08 |
| Date of Event | 2013-05-08 |
| Date Mfgr Received | 2013-05-08 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-06-12 |
| 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 | 2013-05-31 |
| Model Number | STRAPSTAND |
| Catalog Number | 2000 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2013-05-31 |