MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-18 for EASYSTAND STRAPSTAND 2000 manufactured by Altimate Medical, Inc..
[3987108]
Received a call from the product user that the strap tore away from the padded seat body of the large adjustable seat strap on an easystand strapstand. When this occurred the user fell back into his chair. The user was not injured.
Patient Sequence No: 1, Text Type: D, B5
[11513073]
Upon review of this issue, the current inventory of the adjustable straps at altimate medical was tested at 1. 5 times the maximum advertised user weight limit. 70 straps were tested internally and of out of those 70, three of the straps had one side where the strap tore away from the main seat body. This appears to have been caused by inconsistent manufacturing processes at the supplier who manufactures these straps. Altimate medical is working on updating and adding additional information to the product specifications for this component and is communicating with the supplier regarding their quality control processes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183634-2013-00006 |
| MDR Report Key | 3633603 |
| Report Source | 04 |
| Date Received | 2013-12-18 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-11-26 |
| Date Mfgr Received | 2013-11-26 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2014-04-01 |
| 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 | 2013-12-18 |
| Model Number | STRAPSTAND |
| Catalog Number | 2000 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-12-18 |