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 |