MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-22 for AMNISURE * manufactured by Amnisure International.
[17408320]
An amnisure test was opened to be used on a patient, and the test vial was found to be dry. Test can not be performed without a vial with solvent that extracts the sample substance from the swab. ====================== manufacturer response for amnisure test, amnisure (per site reporter)======================vendor provided additional amnisure test kits at no expense.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2225297 |
| MDR Report Key | 2225297 |
| Date Received | 2011-08-22 |
| Date of Report | 2011-08-22 |
| Date of Event | 2011-08-19 |
| Report Date | 2011-08-22 |
| Date Reported to FDA | 2011-08-22 |
| Date Added to Maude | 2011-08-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE |
| Generic Name | AMNISURE TEST |
| Product Code | NQM |
| Date Received | 2011-08-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | A10012012/12 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMNISURE INTERNATIONAL |
| Manufacturer Address | 24 SCHOOL STREET 6TH FLOOR BOSTON MA 02108 US 02108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-22 |