MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-08 for VEST MODEL 105 P105 manufactured by Hill-rom Singapore.
[99324353]
The account alleged that the use of the vest caused her to be sore. She went for evaluation when it was discovered that she had some slightly fractured ribs. No treatment was provided as the patient was diagnosed as already healing. The use of the vest combined with the patient's underlying pathology may have contributed to her fractured ribs. The account did not allege the device malfunctioned and will continue use. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[99324354]
Hill-rom received a report from the account stating the patient suffered fractured ribs. The bed was located at the account. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2018-00002 |
| MDR Report Key | 7250943 |
| Report Source | CONSUMER |
| Date Received | 2018-02-08 |
| Date of Report | 2018-01-10 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2018-01-10 |
| Date Added to Maude | 2018-02-08 |
| 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 | 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 | VEST MODEL 105 |
| Generic Name | PERCUSSOR, POWERED ELECTRIC |
| Product Code | BYI |
| Date Received | 2018-02-08 |
| Model Number | P105 |
| 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 | 2018-02-08 |