MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-27 for THERABAND * 542105 ( SAMMONS AND PRESTON) manufactured by The Hygenic Corporation.
[376499]
A cardiac rehabilitation patient was performing thera-band rowing exercise. The thera-band tore from it's attachment and rebounded back into the patient's lower sternum, resulting in a noticeable reddening and a small hematoma at the bottom of their surgical incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 563678 |
| MDR Report Key | 563678 |
| Date Received | 2004-12-27 |
| Date of Report | 2004-12-27 |
| Date of Event | 2004-12-08 |
| Report Date | 2004-12-27 |
| Date Reported to FDA | 2004-12-27 |
| Date Added to Maude | 2005-01-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABAND |
| Generic Name | EXERCISE BAND |
| Product Code | ISD |
| Date Received | 2004-12-27 |
| Model Number | * |
| Catalog Number | 542105 ( SAMMONS AND PRESTON) |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 553407 |
| Manufacturer | THE HYGENIC CORPORATION |
| Manufacturer Address | THERA-BAND DIVISION 1245 HOME AVE AKRON OH 44310 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-27 |