MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-21 for NB SCREENING FORMS manufactured by Unknown.
[81157247]
With new lysol all storage abnormalities. I'm getting 75 percent false positive results. Every birth. Diagnosis or reason for use: birth. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071229 |
| MDR Report Key | 6743550 |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-07-03 |
| Date Added to Maude | 2017-07-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NB SCREENING FORMS |
| Generic Name | NB SCREENING FORMS |
| Product Code | LDM |
| Date Received | 2017-07-21 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | BARNET MO 65084 US 65084 |
| Brand Name | NB SCREENING FORMS |
| Generic Name | NB SCREENING FORMS |
| Product Code | JKA |
| Date Received | 2017-07-21 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EASTERN BUSINESS FORMS |
| Manufacturer Address | BARNET MO 65084 US 65084 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly | 2017-07-21 |