MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-06-13 for CONTROLLER, VEST 105 P105CM manufactured by .
[4571570]
The patient reported that she had pain in her back immediately following a treatment from the vest. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12108015]
The patient contacted hill-rom and stated she had broken her humerus near her shoulder sometime in the winter. She did not use the vest during the healing time, until her doctor appointment for follow up on (b)(6). She restarted her vest therapy sometime after the appointment and stated she used the device 2 or 3 times. During the first two times of restarting the vest therapy, it went well, no reported pain. The patient stated that after completing the third treatment session, she experienced severe pain in her back and was stooped over. She stated the pain occurred immediately. She reports using the settings that she was trained on but could not confirm. She did not fall and cannot recall anything else that may have contributed to the pain. She went to the e. R. For evaluation and then was admitted for a couple of days; x-rays and ct scan were ordered and was later diagnosed with severe osteoporosis. She stated the doctor at the hospital diagnosed her with two crushed vertebrae. She had been diagnosed with osteoporosis several years ago but did not realize how severe the osteoporosis had progressed. The vest was sent back to hill-rom for investigation and the engineering investigation concluded that the vest passed all performance testing and did function as designed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2014-00005 |
| MDR Report Key | 3883931 |
| Report Source | 04 |
| Date Received | 2014-06-13 |
| Date of Report | 2014-05-15 |
| Date of Event | 2014-05-15 |
| Date Mfgr Received | 2014-05-15 |
| Date Added to Maude | 2014-06-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER, VEST 105 |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2014-06-13 |
| Model Number | P105CM |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-13 |