MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-08-17 for CVS PHARMACY CVS MODEL 741741 NA manufactured by Foshan R. Poon Medical Products Co., Ltd..
[19365325]
Drive medical has received a complaint from one of our customers, (b)(6), alleging an adverse event involving a raised toilet seat, originally imported for (b)(6) by drive medical. It is reported that the toilet seat was purchased from (b)(6) and installed by claimant's wife and his daughter prior to the event. Allegedly, the claimant was in rush to sitting down on the toilet seat and the seat slid out on his right side under him and caused his hip to hit the toilet rim. The claimant was transported via ambulance to the hospital and diagnosed with right hip fracture. He remained in-patient for two days prior to his release. There is no defect and/or malfunction has been reported to drive medical by this time. This mdr report is based on the letter of notice and additional info provided by (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2012-00014 |
| MDR Report Key | 2707810 |
| Report Source | 99 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-07-19 |
| Date of Event | 2012-04-15 |
| Date Facility Aware | 2012-07-19 |
| Report Date | 2012-08-17 |
| Date Reported to Mfgr | 2012-08-17 |
| Date Added to Maude | 2012-08-22 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVS PHARMACY |
| Generic Name | RAISED TOILET SEAT |
| Product Code | INB |
| Date Received | 2012-08-17 |
| Model Number | CVS MODEL 741741 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. |
| Manufacturer Address | FOSHAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-08-17 |