MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-24 for CONTROLLER, VEST P105CM manufactured by Hill-rom Singapore.
[48130362]
The device was being used by the patient when they alleged that they began feeling tenderness in their rib area. The patient had been using the vest 3-4 times per day for 20 minutes for 5 days when the issue occurred. The patient followed up with the physician who ordered and x-ray that confirmed 2 broken ribs. The account made no allegation of the vest malfunctioning. Based on this information, no further action is required. This is a serious injury per fda definition.
Patient Sequence No: 1, Text Type: N, H10
[48130363]
Hill-rom received a report from the account stating they suffered 2 fractured ribs while using the vest. The vest was located at the account. There was patient/user injury reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2016-00002 |
| MDR Report Key | 5748400 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-24 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-05-20 |
| Date Mfgr Received | 2016-05-25 |
| Date Added to Maude | 2016-06-24 |
| 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 | JOHN CUMMINGS |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER, VEST |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2016-06-24 |
| Model Number | P105CM |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-24 |