MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-07-30 for DAILY ACTIVITY ASSIST DEVICES 6599 manufactured by Unknown.
[18527971]
Consumer's wife called stating that when the consumer utilizes the 6599 bariatric drop arm commode the left drop arm allegedly will not stay locked and the arm collapses when weight is applied. The arm is allegedly loose. The right drop arm is allegedly tight. The consumer had preexisting hip surgery and when the arm drops it allegedly hits him in the hip, causing him horrible pain. No medical intervention was sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2012-00628 |
| MDR Report Key | 2674030 |
| Report Source | * |
| Date Received | 2012-07-30 |
| Date of Report | 2012-07-28 |
| Date Facility Aware | 2012-07-05 |
| Report Date | 2012-07-28 |
| Date Reported to FDA | 2012-07-28 |
| Date Added to Maude | 2012-11-20 |
| 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 FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAILY ACTIVITY ASSIST DEVICES |
| Generic Name | 890.5050 |
| Product Code | INB |
| Date Received | 2012-07-30 |
| Model Number | 6599 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-30 |