FDA Adverse Event
Malfunction
Summary report: N
CURITY IODOFORM PACKING STRIP
MDR report key: 12016716
·
Received June 16, 2021
Report
- Report Number
- MW5101954
- Event Type
- Malfunction
- Date Received
- June 16, 2021
- Date of Event
- June 15, 2021
- Report Date
- June 15, 2021
- Manufacturer
- COVIDIEN / CARDINAL HEALTH
- Product Code
- EFQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
DAUGHTER HAD SURGERY TO REMOVE A CYST ON HER BACK ON (B)(6) 2021 AT (B)(6) BY (B)(6) PA-C. ON (B)(6) 2021 AT THE APPOINTMENT TO HAVE HER STITCHES REMOVED, IT WAS DETERMINED THAT THE WOUND WAS INFECTED. THE PA (B)(6) PACKED THE WOUND WITH EXPIRED IODOFORM PACKING STRIPS. PRODUCT INFORMATION: CURITY IODOFORM PACKING STRIPS, MANUFACTURER: COVIDIEN LLC, (B)(4), LOT NUMBER: 140000794262X, EXPIRATION DATE: 2016-04, REF 7831. MY DAUGHTER WAS STARTED ON CEFALEXIN BID FOR 10 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 902811 | CURITY IODOFORM PACKING STRIP | GAUZE/SPONGE, INTERNAL | EFQ | COVIDIEN / CARDINAL HEALTH | 140000794262X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other |