MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-12-31 for ER manufactured by Bte Technologies, Inc..
[4191805]
Job applicant was performing a cart push test utilizing bte evaluation equipment. During this test, the individual was in a staggered stance and one foot was in a plantarflexed position and then went to a neutral position. The individual complained of pain. The clinician who administered the test walked the individual over to the urgent care center (connected to this clinic) to be examined. The clinician left the individual there and contacted him the next day. The job applicant told the clinician that he did not get looked at and his ankle/foot was sore but felt better. During follow up, bte personnel learned that the person had an mri, was diagnosed with a torn achilles tendon, and surgery was performed on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[11429451]
Job applicant pulled a tendon while attempting to perform an exercise while in a physical position that would be required for the job that the person applied for. The injury occurred during exercise that was not bte-device-specific and could have been performed against a wall. The equipment did not cause or contribute to the injury. The device was used in a proper manner, was not malfunctioning, and there was no need to conduct a specific device evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119903-2013-00003 |
| MDR Report Key | 3587105 |
| Report Source | 07 |
| Date Received | 2013-12-31 |
| Date of Report | 2013-12-16 |
| Date of Event | 2013-12-11 |
| Date Mfgr Received | 2013-12-16 |
| Device Manufacturer Date | 2012-12-26 |
| Date Added to Maude | 2014-01-23 |
| 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 | ER |
| Generic Name | IKK-SYSTEM, ISOKINETIC TESTING & EVALUATION |
| Product Code | IKK |
| Date Received | 2013-12-31 |
| Model Number | ER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2013-12-31 |