FDA Adverse Event
Summary report: N
LITE TOUCH U-100 INSULIN SYRINGE
MDR report key: 262410
·
Received February 14, 2000
Report
- Report Number
- MW1018130
- Date Received
- February 14, 2000
- Manufacturer
- MEDICORE, INC.
- Product Code
- FMF
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 3/17/00: MFR IS IN THE PROCESS OF IDENTIFYING CUSTOMERS THAT PURCHASED 1CC SYRINGES, CONTACTING THEM TO GET A CURRENT INVENTORY. MFR WILL THEN SEND THEM THE APPROPRIATE STICKERS TO CORRECT THE TYPO/ERROR ON BOXES.
Description of Event or Problem · 1
UNDER "1CC" SAYS "FOR 50 UNITS OR LESS" ON SIDES OF BOX. ACTUALLY THIS IS INCORRECT. SHOULD BE FOR 100 UNITS OR LESS - SYRINGES ARE 1CC, MAYBE AREA COULD BE MARKED OUT.
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 3/10/00: MFR TOOK IMMEDIATE STEPS TO CORRECT PROBLEM BY HAVING APPROPRIATE STICKERS PRINTED TO STICKER OVER MISTAKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LITE TOUCH U-100 INSULIN SYRINGE | INSULIN SYRINGES | FMF | MEDICORE, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |