MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-02-13 for LOCKING ELEVATED TOILET SEAT MDS80316 * manufactured by Medline Industries, Inc..
[611826]
The locking elevated toilet seat reportedly came off of the toilet while a physical therapist was assisting the user. This occurred during a visit by the physical therapist to the end user's home. The physical therapist reports that the seat seemed to be secure; however, while assisiting the patient in the bathroom, the toilet seat "flipped off" the toilet. The physical therapist was able to hold onto the patient; so she did not fall and was not injured. No additional information was available.
Patient Sequence No: 1, Text Type: D, B5
[7874159]
The device is expected to be returned for evaluation. It has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2007-00008 |
| MDR Report Key | 835083 |
| Report Source | 04 |
| Date Received | 2007-02-13 |
| Date of Report | 2007-01-31 |
| Date Mfgr Received | 2007-01-31 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2007-04-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOCKING ELEVATED TOILET SEAT |
| Generic Name | ELEVATED TOILET SEAT |
| Product Code | LDQ |
| Date Received | 2007-02-13 |
| Model Number | MDS80316 |
| Catalog Number | * |
| Lot Number | R060128035 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 822406 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-13 |