MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-17 for AMNISURE manufactured by Amnisure International Llc.
[690484]
We rec'd a recall from the mfr of amnisure rom testing devices. After review of the recall data, it is my concern that the test no longer falls into "waived category" definitions. Dilutions of the specimen at the bedside is neither practical or within the scope of practice for most of the personnel that would be performing the test. Also, the data in the recall describing the so called "hook effect" is definitely out of the area of expertise for most of the would be testing personnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004137 |
| MDR Report Key | 930574 |
| Date Received | 2007-10-17 |
| Date of Report | 2007-10-17 |
| Date of Event | 2007-10-17 |
| Date Added to Maude | 2007-11-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | AMNISURE |
| Generic Name | AMNISURE ROM TEST |
| Product Code | NQM |
| Date Received | 2007-10-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 904747 |
| Manufacturer | AMNISURE INTERNATIONAL LLC |
| Manufacturer Address | CAMBRIDGE MA 02138 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-17 |