MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for SPA SAFETY SERIES DRIVE PREMIUM SHOWER CHAIR WITH FOLDING BACK #BRTL 12606-AST manufactured by Drive - Devilbiss Healthcare / Columbia Medical, Llc.
[181125397]
Using spa folding back shower chair, item # brtl 12606-ast, the legs collapsed. I fell in the shower, 911 was called by wife. The 911 respondents elevated me into the ambulance for a trip to (b)(6) hosp er. Had cat scan, after 4 hours in er released with medical report. Contacted mfr on 02/18/2020. They promised a same day response which has not occurred. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093232 |
| MDR Report Key | 9750281 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-11 |
| Date Added to Maude | 2020-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | SPA SAFETY SERIES DRIVE PREMIUM SHOWER CHAIR WITH FOLDING BACK |
| Generic Name | ADAPTOR, HYGIENE |
| Product Code | ILS |
| Date Received | 2020-02-24 |
| Model Number | #BRTL 12606-AST |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRIVE - DEVILBISS HEALTHCARE / COLUMBIA MEDICAL, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-24 |