D
Patient 1
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.
MAUDE MDR 6743550
- MDR report key
- 6743550
- Report number
- MW5071229
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-03
- Date received
- 2017-07-21
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | NB SCREENING FORMS | NB SCREENING FORMS | UNKNOWN | LDM | I | Y | ||||||
| 1 | NB SCREENING FORMS | NB SCREENING FORMS | EASTERN BUSINESS FORMS | JKA | I | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-07-21 | 0 | 1. C |