MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-07-21 for THERABAND manufactured by Hygenic Corporation.
[50076932]
Report is under investigation. Have not confirmed this to be a hygenic product at this time. Product has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[50076933]
On (b)(6) 2015 patient had an incident in which a theraband standard ball malfunctioned and collapsed. This malfunction caused severe orthopedic injuries including a ruptured disc. The injuries will require surgery. We do not know which standard ball this was.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519375-2016-00005 |
| MDR Report Key | 5811682 |
| Report Source | OTHER |
| Date Received | 2016-07-21 |
| Date of Report | 2016-07-20 |
| Date of Event | 2015-12-14 |
| Date Mfgr Received | 2016-06-21 |
| Date Added to Maude | 2016-07-21 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA PIERO |
| Manufacturer Street | 1245 HOME AVE |
| Manufacturer City | AKRON OH 44310 |
| Manufacturer Country | US |
| Manufacturer Postal | 44310 |
| Manufacturer Phone | 3306342238 |
| Manufacturer G1 | HYGENIC CORPORATION |
| Manufacturer Street | 1245 HOME AVE. |
| Manufacturer City | AKRON OH 44310 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44310 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABAND |
| Generic Name | STANDARD EXERCISE BALL |
| Product Code | ION |
| Date Received | 2016-07-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGENIC CORPORATION |
| Manufacturer Address | 1245 HOME AVE. AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-21 |