MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-04 for EASYSTAND EVOLV EVOLV MEDIUM NG50162 manufactured by Altimate Medical, Inc..
[15321426]
On (b)(6) 2015, altimate medical (ami) customer svc received a call from a facility regarding a broken thread on a caster. The following add'l info was obtained on (b)(6) 2015 from the facility: the thread on one of the back casters broke and the back end of the frame went down to the floor. , causing the stander to be uneven. The teacher saw this and helped the child in the unit lay on the floor. Help arrived and three people then stood the stander back up and two more lifted the child out of the stander. The nursing staff at this facility checked over the child and he appeared to be ok, however, the parent of the child wanted him taken to the emergency room by ambulance to be further checked out. On (b)(6) 2015 attempts were made to gather further info but the facility was unable to provide any further info at the time.
Patient Sequence No: 1, Text Type: D, B5
[15767030]
On f/u attempts to obtain add'l info, the facility has been unable to provide add'l info at this time. However, the facility stated they will keep in contact with ami and let us know when they can provide add'l info. In addition, ami has requested to have the caster and the base returned so this issue can be investigated. The facility is unable to return the components at this time but stated it will f/u with ami if and/or when they can return the components to ami.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183634-2015-00001 |
| MDR Report Key | 4490879 |
| Report Source | 06 |
| Date Received | 2015-02-04 |
| Date of Report | 2015-01-06 |
| Date of Event | 2015-01-06 |
| Date Mfgr Received | 2015-01-06 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2015-03-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 EVOLV |
| Generic Name | 890.3110 |
| Product Code | ION |
| Date Received | 2015-02-04 |
| Model Number | EVOLV MEDIUM |
| Catalog Number | NG50162 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-02-04 |