MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-16 for ALTUS EXERCISE BALL manufactured by Altus Athletic Manufacturing, Inc..
[48346615]
Woman in labor sitting on altus exercise ball which suddenly burst, causing her so fall backwards hitting head and sacrum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063006 |
| MDR Report Key | 5748338 |
| Date Received | 2016-06-16 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-06-16 |
| Date Added to Maude | 2016-06-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALTUS EXERCISE BALL |
| Generic Name | ALTUS EXERCISE BALL |
| Product Code | ION |
| Date Received | 2016-06-16 |
| Device Expiration Date | 2017-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTUS ATHLETIC MANUFACTURING, INC. |
| Manufacturer Address | ALTUS OK 73522 US 73522 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-16 |