MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for DRIVE RTL13084 manufactured by Unknown.
[138834585]
(b)(4) is th initial importer of the device which is a grabber. The end-user grabbed the bar when the green indicator was activated. However the pin wasn't in there and the person fell he went tot he emergency room. The patient was injured. C3- c6 bones and is currently doing physical therapy. He may need surgery later on. The patient is 6ft and (b)(6). He has been using the device for 2 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00006 |
| MDR Report Key | 8422031 |
| Date Received | 2019-03-14 |
| Date Facility Aware | 2019-02-27 |
| Report Date | 2019-03-14 |
| Date Reported to FDA | 2019-03-14 |
| Date Added to Maude | 2019-03-14 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | DRIVE |
| Generic Name | GRABBAR |
| Product Code | ILS |
| Date Received | 2019-03-14 |
| Model Number | RTL13084 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-14 |