FDA Adverse Event Injury Summary report: N

TEGADERM CHG DRESSING

MDR report key: 1894580 · Received November 5, 2010

Report

Report Number: 2110898-2010-00124
Event Type: Injury
Date Received: November 5, 2010
Date of Event: October 3, 2010
Report Date: October 7, 2010
Manufacturer: 3M HEALTH CARE
Product Code: FRO
PMA / PMN Number: K080620
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

CONCLUSIONS: NO EVAL WILL BE PERFORMED. DEVICE OR LOT CODE NOT PROVIDED TO MFR FOR EVAL. COMPLAINT TYPE WILL BE MONITORED. THE INSERT PROVIDES THE FOLLOWING INFO REGARDING OBSERVATION AND WHEN A DRESSING SHOULD BE CHANGED. SITE CARE: THE SITE SHOULD BE OBSERVED DAILY FOR SIGNS OF INFECTION OR OTHER COMPLICATIONS. IF INFECTION IS SUSPECTED, REMOVE THE DRESSING, INSPECT THE SITE DIRECTLY, AND DETERMINE APPROPRIATE MEDICAL INTERVENTION. INFECTION MAY BE SIGNALED BY FEVER, PAIN, REDNESS, SWELLING, OR UNUSUAL ODOR OR DISCHARGE. CHANGE THE DRESSING AS NECESSARY, IN ACCORDANCE WITH FACILITY PROTOCOL; DRESSING CHANGES SHOULD OCCUR AT LEAST EVERY 7 DAYS, PER CURRENT CDC RECOMMENDATIONS. DRESSING CHANGES MAY BE NEEDED MORE FREQUENTLY WITH HIGH EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED.

Description of Event or Problem · 1

HEALTH CARE FACILITY REPORTED THAT A PT HAD DEVELOPED A SKIN IRRITATION UNDER THE ENTIRE DRESSING AT THE INSERTION SITE. THE CATHETER WAS REMOVED IN RESPONSE TO THE SKIN REACTION. A TOPICAL ANTIBIOTIC CREAM (MUPIROCIN) WAS USED TO TREAT THE CONDITION. THE OUTCOME OF THE SKIN CONDITION IS UNK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TEGADERM CHG DRESSING	ANTIMICROBIAL IV SECUREMENT DRESSING	FRO	3M HEALTH CARE	NA	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	CHLORAPREP\| IV FLUIDS\| CATHETER SECURED WITH RETENTION SUTURES\| STAT-LOCK\| ANTIBIOTICS