MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-02 for SCHUREMED CORPORATION 800-0004 manufactured by Schuerch Corporation.
[3249141]
The product's mfg does not come up at the fda web site to indicate if the product is approved to be used as intended by the mfr. It's being used in the operating room with arthroscope procedures where there is fluid involved for shoulder surgeries. Web site www. Schuremed. Com. Potential injury could occur to pt similar to the osi recall on its traction tables that came out in the past. Mfr states it's a class 1 device, but since it's a 110v device used in the operating room it's questionable if it was really appropriately presented as such.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029606 |
| MDR Report Key | 3039981 |
| Date Received | 2013-04-02 |
| Date of Report | 2013-04-02 |
| Date Added to Maude | 2013-04-09 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHUREMED CORPORATION |
| Generic Name | POWERED BEACH CHAIR |
| Product Code | GBB |
| Date Received | 2013-04-02 |
| Model Number | 800-0004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHUERCH CORPORATION |
| Manufacturer Address | BRAINTREE MA 02184 US 02184 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-02 |