FDA Adverse Event Injury Summary report: N

MINI SHEET

MDR report key: 2631136 · Received June 20, 2012

Report

Report Number: 1035617-2012-00004
Event Type: Injury
Date Received: June 20, 2012
Date of Event: May 1, 2012
Report Date: May 25, 2012
Manufacturer: ZIMMER SURGICAL
Product Code: FPY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT RETURNED FOR EVAL. THERE WAS INDICATION OF LOT NUMBER, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. UNABLE TO DETERMINE CAUSE OF COMPLAINT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ZIMMER ULTRACARE WOUND SHEET IS HOLDING IN MOISTURE AND CAUSING SKIN IRRITATION. ADDITIONAL CLINICAL FOLLOW UP INDICATED THAT THE SHEETING WAS REPORTED TO HAVE BEEN USED FOR A PREMATURE INFANT THAT WAS IN A THERMOSTATICALLY CONTROLLED (35-37 DEGREE CELSIUS) ENVIRONMENT. AFTER "A BRIEF PERIOD" THE CUSTOMER NOTED THE INFANT'S SKIN TO BE RED AND PEELING. AN OINTMENT WAS APPLIED TO TREAT THE SKIN. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE USE OF WOUND SHEETING HAS BEEN ROUTINE IN THE NICU (NEONATAL INTENSIVE CARE UNIT) AT THE FACILITY SINCE AT LEAST 2000. THE CUSTOMER WAS UNABLE TO PROVIDE INFO REGARDING WHY THE PRODUCT WAS CHOSEN. NO OTHER INFO REGARDING THE REASON FOR USE OF WOUND SHEETING WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MINI SHEET	MINI SHEET	FPY	ZIMMER SURGICAL	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1