MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for DRIVE RTL13083 manufactured by Unknown.
[136284274]
(b)(4) is the initial importer of the device which is a grab bar. The end-user acquired the device for assistance in and out of bathtub. She was using the device prior to undergoing a total knee replacement surgery on (b)(6) 2018. The product detached from wall while end user was getting out of the shower. The patient was diagnosed with torn patellar tendon which required surgery and a knee brace for 8 weeks. This procedure took place on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00003 |
| MDR Report Key | 8344034 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-01-02 |
| Date Facility Aware | 2019-02-07 |
| Date Added to Maude | 2019-02-15 |
| 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 | GRAB BAR |
| Product Code | ILS |
| Date Received | 2019-02-15 |
| Model Number | RTL13083 |
| 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 | 1. Required No Informationntervention | 2019-02-15 |