MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-06 for BARTON? MEDICAL CONVERTIBLE? I-700 * manufactured by Barton Medical Corp..
[19610647]
Two rehab experianced na's were giving patient a shower on a bariatric shower chair. A peg slipped out of hole and one leg dropped about 2 inches lower than other 3 legs. Patient was always on the seat. Both na's were right next to patient. Patient did not fall. Patient did not hit anything. Patient stated she was fine. All the rest of shift patient states she was happy. Patient smiling and very content. No complaints of any kind. On next shift, patient started to complain of generalized aches and pains in knees and back. Patient stated to them that she was not sure if it was the shower chair sudden slant, or the po lasix she got that made her get up and down so many times to urinate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4598401 |
| MDR Report Key | 4598401 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-03-05 |
| Date of Event | 2015-02-07 |
| Report Date | 2015-03-05 |
| Date Reported to FDA | 2015-03-06 |
| Date Reported to Mfgr | 2015-03-13 |
| Date Added to Maude | 2015-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARTON? MEDICAL CONVERTIBLE? |
| Generic Name | BARIATRIC CHAIR |
| Product Code | FMR |
| Date Received | 2015-03-06 |
| Model Number | I-700 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARTON MEDICAL CORP. |
| Manufacturer Address | 5725 HWY 290 WEST #103 AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-06 |