FDA Adverse Event Injury Summary report: N

TEGADERM CHG DRESSING

MDR report key: 1802557 · Received August 10, 2010

Report

Report Number: 2110898-2010-00088
Event Type: Injury
Date Received: August 10, 2010
Date of Event: May 12, 2010
Report Date: July 9, 2010
Manufacturer: 3M HEALTHCARE
Product Code: FRO
PMA / PMN Number: K080620
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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 HIGHLY EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED.

Description of Event or Problem · 1

HEALTH CARE FACILITY REPORTED THAT A PT HAD A REACTION, DESCRIBED AS A MUSHY AND GRAY AREA UNDER THE GEL PAD, AFTER THE DRESSING WAS REMOVED FROM THE PT'S SKIN. THE PICC LINE / CATHETER WERE REMOVED. THE FACILITY REPORTED THAT THE SKIN CONDITION WAS IMPROVING AND THAT NO FURTHER TREATMENT WAS NEEDED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	88 YR		Required Intervention	PICC LINE\| STAT-LOCK\| CHLORAPREP (FOR SKIN ANTISEPSIS)\| CATHETER