MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-06 for THERABAND 20530 manufactured by Hygenic Corporation.
[85088229]
Follow up call 8/15/2017. Band split on the short side. Band was purchased in (b)(6) 2017 and was used 1-2 times per week. She inspected the band at purchase, but not on the day it was used and broken. The band was disposed of at the physician's office and was exchanged for a blue/black band, which is a higher resistance level.
Patient Sequence No: 1, Text Type: N, H10
[85088230]
Customer called on (b)(6) 2017 to report an incident that occurred on (b)(6) 2017. Her red theraband broke during an exercise, causing her to fall and injure her finger tips, neck and back. She had the theraband around a giselle machine-stationary part. She pulled in to build her forearm and bicep, held for 3 seconds, and the band "split" which caused her to lose her balance and fall backward and down. She landed on her right side wrist/arm and forearm and is having loss of grip strength.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519375-2017-00001 |
| MDR Report Key | 6846719 |
| Report Source | CONSUMER |
| Date Received | 2017-09-06 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-09-06 |
| 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 | PATIENT |
| 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 | RESISTANCE BAND |
| Product Code | ION |
| Date Received | 2017-09-06 |
| Model Number | 20530 |
| 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 | 2017-09-06 |