MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-24 for EASYSTAND STRAPSTAND 2000 manufactured by Altimate Medical, Inc..
[4547143]
Received a call from a facility that the stitching came loose on the large strap, part no. 80719 on their easystand strapstand standing frame. The facility has had the unit since (b)(6) 2007 and they use the unit every day with approximately 10 different residents. The user's wheelchair is positioned up to the standing frame so it's available when the user goes back to the seated position, therefore, no injuries were reported when the stitching came loose.
Patient Sequence No: 1, Text Type: D, B5
[11832521]
After discussing this issue further with the facility, it was determined that this facility has had the standing frame for approximately 7 years and uses the device on a daily basis with 10 different residents. It is assumed that the stitching came loose on this strap due to amount of time that this product has been used. The facility stated that overall the product is in good condition and that they would like two replacement straps due to the amount that this product is used. Altimate provided the facility with two replacement straps per their request.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183634-2014-00001 |
| MDR Report Key | 3748051 |
| Report Source | 06 |
| Date Received | 2014-01-24 |
| Date of Report | 2014-01-07 |
| Date of Event | 2014-01-07 |
| Date Mfgr Received | 2014-01-07 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2014-05-08 |
| 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 | 2014-01-24 |
| Returned To Mfg | 2014-01-16 |
| Model Number | STRAPSTAND |
| Catalog Number | 2000 |
| Lot Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-01-24 |