MalfunctionNGE

UP AND UP OVULATION TEST

Received Jun 3, 2017 · Event occurred May 28, 2017

Report MW5070212 · MDR key 6618492

Device

Generic name

Test, Luteinizing Horone

Manufacturer

Mfr Unk

Model number

359726558075

Lot number

2802171

Product problems

Defective Component

Patient

34 YR

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

UP AND UP BRAND 7 COUNT OVULATION TEST PLUS 1 PREGNANCY TEST. (B)(4). THREE OF THE SEVEN TEST STRIPS APPEAR DEFECTIVE/ NOT WORKING PROPERLY. NO CHANGE/CONTROL APPEARS IN WINDOW. LOT: 2802171.