MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-10 for EASYSTAND STRAPSTAND 2000 manufactured by Altimate Medical, Inc..
[33186695]
This standing frame is just over 4 years old and was a representative sample, therefore it is assumed the unit was used quite frequently. The strap from this issue was returned and visually inspected. Upon inspection is was determined that this strap failed because the strap was not sewn all the way into the reinforced stitches on the strap. The sales representative requested an extra-large adjustable seat strap as the replacement strap for this unit and the replacement strap was shipped by altimate medical to address this issue.
Patient Sequence No: 1, Text Type: N, H10
[33186696]
Received an email from (b)(6), an ami independent rep, that the large adjustable seat strap on his strapstand sample unit had failed and that he needed a replacement strap. The facility that was using the strapstand at the time had a user that was approximately (b)(6) lbs. And was about 45 degrees from sitting to standing when one side of the strap tore away from the body of the seat strap. The user had been sitting on a high-low mat (gym mat), therefore when the strap tore away the user was supported by the mat underneath them. No injuries to the user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183634-2015-00006 |
| MDR Report Key | 5286250 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-10 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-11-12 |
| Date Mfgr Received | 2015-11-12 |
| Device Manufacturer Date | 2011-10-04 |
| Date Added to Maude | 2015-12-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. STACEY FRANK |
| Manufacturer Street | 262 WEST FIRST STREET |
| Manufacturer City | MORTON MN 56270 |
| Manufacturer Country | US |
| Manufacturer Postal | 56270 |
| Manufacturer Phone | 5076976393 |
| Manufacturer G1 | ALTIMATE MEDICAL, INC. |
| Manufacturer Street | 262 WEST FIRST STREET |
| Manufacturer City | MORTON MN 56270 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56270 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYSTAND STRAPSTAND |
| Generic Name | STANDING FRAME |
| Product Code | ION |
| Date Received | 2015-12-10 |
| Returned To Mfg | 2015-12-01 |
| Model Number | STRAPSTAND |
| Catalog Number | 2000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTIMATE MEDICAL, INC. |
| Manufacturer Address | 262 WEST FIRST STREET MORTON MN 56270 US 56270 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-10 |