MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for DRIVE 12202KD manufactured by Zhongshan Bliss Medical Instrument Co., Ltd.
[144328680]
(b)(4) healthcare is the initial importer of the device which is a bath safety chair. Model number of the chair has not been confirmed. Product has not been recovered for evaluation. End user was taking a shower. She felt the chair lean. She stood up, shifted it, and sat back down. This scenario repeated. She tried to shift it and fell on her back. The rear left leg reportedly bent. End user suffers from spinal stenosis. The incident aggravated her condition. She went to a doctor for pain management and was prescribed pain meds. The doctor referred her to a neurosurgeon. She had an epidural on 4/3 approximately 2 weeks after the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00024 |
| MDR Report Key | 8588136 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-03-15 |
| Date Facility Aware | 2019-03-27 |
| Report Date | 2019-05-07 |
| Date Reported to FDA | 2019-05-07 |
| Date Added to Maude | 2019-05-07 |
| 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 | BATH SAFETY |
| Product Code | ILS |
| Date Received | 2019-05-07 |
| Model Number | 12202KD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD |
| Manufacturer Address | 98, ZHAOYI ROAD DONGSHENG TOWN, ZHONGSHAN CITY,, GUANGDONG 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |