FDA Adverse Event Malfunction Summary report: N

VITALE DRESSING

MDR report key: 3261253 · Received July 30, 2013

Report

Report Number
MW5031253
Event Type
Malfunction
Date Received
July 30, 2013
Date of Event
June 14, 2013
Report Date
July 19, 2013
Manufacturer
CELLERA LLC
Product Code
NAD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

(B)(4), IDENTIFIED WHAT APPEARED TO BE AN ANOMALY WITH THE PACKAGING OF PELEVERUS AND VITALE DRESSING PRODUCTS FROM CELLERA LLC, LOCATED AT (B)(4) (PRODUCT). THE SKU'S OF THE PRODUCT THAT WERE RECEIVED BY MMS HAD ORIGINAL LABELING ON THE OUTSIDE PACKAGING INDICATING THE PRODUCT HAD EXPIRED. CELLERA HAD PLACED A NEW LABEL WITH A NEW AND DIFFERENT EXPIRATION DATE OVER THE ORIGINAL LABEL. IN ADDITION, THE INSIDE PACKAGING HAD THE OLD, EXPIRED EXPIRATION DATE - THE SAME EXPIRATION DATE THAT WAS ON THE ORIGINAL LABEL. (B)(4) HAS QUARANTINED THE PRODUCT AT THE (B)(4). IN ADDITION TO NOTIFYING CELLERA OF THE ISSUE, (B)(4) IS REQUESTING THAT CELLERA NOTIFY CUSTOMERS OF (B)(4) THAT HAVE PURCHASED PRODUCT FROM (B)(4) AS OF JANUARY 1, 2013. (B)(4) WILL HOLD ALL PRODUCT WITH THE LABELING ANOMALY UNTIL RECEIVING INSTRUCTIONS FROM CELLERA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
356059 VITALE DRESSING NONE NAD CELLERA LLC

Patients

Seq Age Sex Outcome Treatment
1