MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-27 for ECCENTRON ECCENTRON LE1 manufactured by Bte Technologies, Inc..
[4243141]
A patient with an external fixation apparatus on the leg was directed to exercise on bte equipment by a supervising clinician. During the exercise, the patient removed their foot from the equipment's pedal before the equipment was stopped. One of the apparatus pins inserted through the skin came in contact with the equipment pedal causing a small amount of bleeding at the pin's entry site. The patient saw a doctor working at the same facility who determined that this was not an abnormal situation. X-rays were taken and the pin was removed with no further issues reported. The clinic personnel stated that this type of injury is common during leg lengthening treatment and that the bleeding was no worse than the stress of walking.
Patient Sequence No: 1, Text Type: D, B5
[11591516]
The event is unrelated to any problems with bte equipment and was caused by a limb lengthening apparatus worn by the patient. A pin included in this apparatus came in contact with bte equipment causing a small amount of bleeding. This problem can occur during normal activities such as walking or if the patient bumps into an object. Bumping external pin that cause superficial skin bleeding.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119903-2014-00001 |
| MDR Report Key | 3688136 |
| Report Source | 05 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-01-28 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-01-28 |
| Device Manufacturer Date | 2013-10-29 |
| Date Added to Maude | 2014-04-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EWA KACZANOWSKA, MANAGER |
| Manufacturer Street | 7455-L NEW RIDGE RD. |
| Manufacturer City | HANOVER MD 21076 |
| Manufacturer Country | US |
| Manufacturer Postal | 21076 |
| Manufacturer Phone | 4108500333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECCENTRON |
| Generic Name | IKK-SYSTEM, ISOKINETIC TESTING AND EVALUATION |
| Product Code | IKK |
| Date Received | 2014-02-27 |
| Model Number | ECCENTRON LE1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BTE TECHNOLOGIES, INC. |
| Manufacturer Address | 7455-L NEW RIDGE RD. HANOVER MD 21076 US 21076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-27 |