MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for BATHING AND SHOWER SEAT 770-525 manufactured by Aquasense / Medical Depot, Inc., Dba Drive Devilbiss Healthcare/columbia Medical, Llc.
[174672582]
My mother was being bathed and was seated in her aqua sense foldable bath and shower seat. Her caregiver was washing her hair, when the back of the seat spontaneously broke off. My mom then fell backwards in the bathtub, resulting in a two inch laceration on the back. I have the product to prove that it broke and i emailed the company. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092118 |
| MDR Report Key | 9569394 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-22 |
| Date Added to Maude | 2020-01-09 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | BATHING AND SHOWER SEAT |
| Generic Name | ADAPTOR, HYGIENE |
| Product Code | ILS |
| Date Received | 2020-01-08 |
| Model Number | 770-525 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AQUASENSE / MEDICAL DEPOT, INC., DBA DRIVE DEVILBISS HEALTHCARE/COLUMBIA MEDICAL, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |