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.
[47645852]
Every reasonable 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
[47645853]
He was at pt session where he was performing exercises with a theraband. The band broke and struck him in the eyes and face causing severe pain, injuries to face & eyes, & injury to left shoulder.
Patient Sequence No: 1, Text Type: D, B5
[50079037]
Every reasonable effort was made to obtain the device. Device was not returned. We are unable to confirm the device in question is our product. Follow up information: it has been confirmed that this was not a hygenic product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519375-2016-00003 |
| MDR Report Key | 5732709 |
| Report Source | CONSUMER |
| Date Received | 2016-06-17 |
| Date of Report | 2016-06-16 |
| Date of Event | 2014-10-15 |
| Date Mfgr Received | 2015-11-12 |
| 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 Age | DA |
| 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 |