FDA Adverse Event Injury Summary report: N

CVS HONEY PAD SMALL 1.8" X 3" - STL, MC

MDR report key: 7509421 · Received May 11, 2018

Report

Report Number: 9680091-2018-00015
Event Type: Injury
Date Received: May 11, 2018
Date of Event: April 3, 2018
Report Date: April 17, 2018
Manufacturer: DERMA SCIENCES, INC.
Product Code: FRO
PMA / PMN Number: K110546
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED FOR LOT # 033317; THERE IS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S. BIOCOMPATIBILITY DATA SHEET WAS RECEIVED FROM VENDOR AND THE ADHESIVE FORMULATION DID NOT PRODUCE ANY ERYTHEMA AFTER INDUCTION OR CHALLENGE. UNKNOWN ROOT CAUSE. CUSTOMER ENQUIRED THE PRODUCT COMPOSITIONS AND INFORMATION WAS PROVIDED.

Description of Event or Problem · 1

ON (B)(6) 2018, A PATIENT REPORTED AN ALLERGIC REACTION TO THE ADHESIVE WITH CVS937404 CVS HONEY PAD SMALL. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
350021	CVS HONEY PAD SMALL 1.8" X 3" - STL, MC	PRIVATE LABEL - CVS	FRO	DERMA SCIENCES, INC.		033317

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other