MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-12 for VEST MODEL 105 P105 manufactured by Hill-rom Singapore.
[85822404]
The patient experienced severe back pain after treatment. The patient's doctor took an x-ray and found a compression fracture on the patient's spine. Patient stopped use of vest therapy for 2 weeks. Clinical support advised lowering the treatment pressure upon approval from hct. 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
[85822405]
Hill-rom received a report from the account stating the patient experienced back pain and was diagnosed with a compression fracture in her spine as a result of using the device. The device was located at the account. There was a 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 | 3008145987-2017-00002 |
| MDR Report Key | 6859326 |
| Report Source | CONSUMER |
| Date Received | 2017-09-12 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-08-20 |
| Date Mfgr Received | 2017-09-07 |
| Date Added to Maude | 2017-09-12 |
| 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 | ERIN PADGETT |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEST MODEL 105 |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2017-09-12 |
| Model Number | P105 |
| 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 | 2017-09-12 |