MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-04-25 for EASYSTAND STRAPSTAND 2000 manufactured by Altimate Medical, Inc..
[4617498]
Received a call from a woman who purchased a strapstand in (b)(6) 2012 for her husband. She said her and a helper were putting him in the unit when one side of the strap tore away from the padded seat body of the xl adjustable seat strap on an easystand strapstand. The user was not injured but startled when it occurred. Both of them were on each side of him and he fell back into his wheelchair, which is positioned up to the standing frame, so it's available when the user goes back to the seated position.
Patient Sequence No: 1, Text Type: D, B5
[12161344]
The adjustable seat strap was returned to altimate and reviewed. Upon review, it was noted that the inserted strap in the seat missed the last row of stitching. This appears to have been caused by inconsistent manufacturing processes at the supplier who manufactures these straps. Altimate medical has updated the product specifications to add add'l detailed info to the product specifications for this component and has communicated with the supplier regarding their quality control process. Altimate has also implemented a receiving inspection process on this component in addition to the current inspection process performed during the assembly and shipping process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183634-2014-00002 |
| MDR Report Key | 3856174 |
| Report Source | 04 |
| Date Received | 2014-04-25 |
| Date of Report | 2014-03-26 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-03-26 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-06-20 |
| 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 | 2014-04-25 |
| Returned To Mfg | 2014-04-07 |
| Model Number | STRAPSTAND |
| Catalog Number | 2000 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-04-25 |