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