MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-09-09 for LOCKING ELEVATED TOILET SEAT MDS80316 * manufactured by Medline Industries, Inc..
[435565]
Reportedly a pt fell and hit their head while using the elevated toilet seat. Reportedly the arm did not hold. Unk if pt or user injury occurred as a result of incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2005-00011 |
| MDR Report Key | 634257 |
| Report Source | 06 |
| Date Received | 2005-09-09 |
| Date Facility Aware | 2005-07-18 |
| Date Reported to FDA | 2005-09-08 |
| Date Added to Maude | 2005-09-14 |
| 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 | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8479492639 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOCKING ELEVATED TOILET SEAT |
| Generic Name | * |
| Product Code | LDQ |
| Date Received | 2005-09-09 |
| Model Number | MDS80316 |
| Catalog Number | * |
| Lot Number | R041182878 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 623825 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Baseline Brand Name | LOCKING ELEVATED TOILET SEAT |
| Baseline Generic Name | * |
| Baseline Model No | MDS80316 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-09 |