MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-17 for THERABAND manufactured by Hygenic Corporation.
[47645301]
Every reasonsable effort was made to obtain the device. Device was not returned. We are unable to confirm the device in question is our product.
Patient Sequence No: 1, Text Type: N, H10
[47645302]
He was using the exercise band in the bathroom on new years eve when it either broke or slipped from his hand causing him to spin and fall, blinding him in one eye. (this account is from his statement in a news article)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519375-2016-00004 |
| MDR Report Key | 5732718 |
| Report Source | CONSUMER |
| Date Received | 2016-06-17 |
| Date of Report | 2016-06-16 |
| Date of Event | 2014-12-31 |
| Date Mfgr Received | 2015-10-07 |
| Date Added to Maude | 2016-06-17 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | EXERCISE BAND |
| Product Code | ION |
| Date Received | 2016-06-17 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Other | 2016-06-17 |