MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for PROVIDENCE 8626-12 MOCHA 486 MOCHA manufactured by Unk.
[142615949]
This consumer is reporting a chair that he purchased for his disabled brother. This chair lifts a person to a stand up position and in his brother's case it is because he cannot lift himself. The brother dropped some sort of a plastic bottle around (b)(6) 2019 on the flow that went under the chair and when the brother used the chair to stand himself up the bottle under the chair damaged the mechanism under the chair. This caller states that he is creating the report because there is room for a child to crawl under the chair and he believes that if a child was under the chair, it could crush or otherwise injure that child. There are no injuries being reported. He contacted the mfr who told him that was like running over a nail in the road. Purchase date: (b)(6) 2019. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085981 |
| MDR Report Key | 8527930 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-12 |
| Date Added to Maude | 2019-04-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVIDENCE |
| Generic Name | CHAIR, POSITIONING, ELECTRIC |
| Product Code | INO |
| Date Received | 2019-04-17 |
| Model Number | 8626-12 MOCHA 486 MOCHA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-17 |