CVS

Report

• Report Number: 1054358-2016-10001
• Event Type: Injury
• Date Received: August 19, 2016
• Date of Event: July 21, 2016
• Report Date: August 16, 2016
• Manufacturer: KOBAYASHI CONSUMER PRODUCTS LLC.
• Product Code: IMD
• UDI-DI: 00050428129722
• PMA / PMN Number: EXEMPT
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: GA, US
• Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH THE ACTUAL DEVICE WAS DISCARDED BY THE PATIENT AND NOT RETURNED, THE MANUFACTURER HAS REVIEWED THIS BATCH FROM A MANUFACTURING AND TECHNICAL PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THE REVIEW OF BATCH RECORDS, TESTING DATA OR INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT SPECIFICATIONS AND THE PRODUCT IS WITHIN EXPIRATION DATE. AFTER A REVIEW OF THE THERMAL BATCH RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. THE REVIEW OF THE RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE CONSUMER'S NOT ADHERING TO THE WARNINGS ON THE PACKAGE RESULTED IN MISUSE OF THE PRODUCT.

Description of Event or Problem · 1

BLISTERS ON BOTH SIDES OF RIGHT ANKLE. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. ON (B)(6) 2016, THIS (B)(6) FEMALE PATIENT OF UNSPECIFIED ETHNICITY, APPLIED THE PRODUCT DIRECTLY TO HER SKIN TO EASE THE PAIN FROM A SPRAINED ANKLE. OTHER THAN HAVING ARTHRITIS IN BOTH KNEES, THE PATIENT DID NOT REPORT ANY FURTHER MEDICAL HISTORY OR CONCOMITANT MEDICATIONS. THE PATIENT STATED THAT THE PRODUCT "BURNED THE INSIDE AND THE OUTSIDE OF HER ANKLE". THE PATIENT STATED THAT THE INCIDENT HAPPENED ON A THURSDAY, THEN SHE" LEFT THE COUNTRY AND THE BURN HAS BEEN GETTING WORSE EACH DAY". THE PATIENT ADVISED THAT SHE VISITED HER DOCTOR AND WAS PRESCRIBED UNSPECIFIED MEDICATION FOR HER BURNS. THE PATIENT STATED THAT THE PHYSICIAN INFORMED HER THAT THIS INCIDENT WILL LEAVE HER SKIN WITH MARKS ON THE INSIDE AND THE OUTSIDE OF HER ANKLE. THE PATIENT STATED THAT HER ANKLE WAS NOT SWELLING AND SHE BOUGHT THE WRAP FOR THE PAIN OF A SPRAINED ANKLE. THE PATIENT PROVIDED PICTURES OF THE AFFECTED AREA, ALONG WITH HER DOCTOR'S DIAGNOSIS STATEMENT. THE PATIENT HAS UNUSED PRODUCT AND WILL PROVIDE THE UNUSED PRODUCT FOR EVALUATION. THE ACTUAL DEVICE THAT SUPPOSEDLY CAUSED THE INJURY WAS DISCARDED BY THE PATIENT AND IS NOT AVAILABLE FOR TESTING. THE WARNINGS PANEL ON THE PRODUCT STATES, "IF YOU ARE 55 YEARS OF AGE OR OLDER, WEAR THE WRAP OVER A LAYER OF CLOTHING AND NOT DIRECTLY AGAINST YOUR SKIN, AS YOUR RISK FOR BURNS INCREASE WITH YOUR AGE." THE PATIENT APPLIED THE PRODUCT DIRECTLY AGAINST HER SKIN. BEING (B)(6) THE PATIENT SHOULD HAVE WORN THE PRODUCT OVER A LAYER OF CLOTHING TO REDUCE THE POSSIBILITY OF BURNS. THEREFORE, THE WARNINGS ON THE PACKAGING WERE NOT FOLLOWED RESULTING IN MISUSE OF THE PRODUCT. THE MANUFACTURER TESTED RETAINED SAMPLES FROM THE SPECIFIED LOT AND FOUND THE PRODUCT PERFORMED WITHIN SPECIFICATIONS WITH NO EVIDENCE OF DEFECT OR MALFUNCTION. CASE COMMENT: BASED ON INFORMATION PROVIDED, THE EVENT BURN BLISTERS AS DESCRIBED IN THIS CASE REPRESENTS A SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT FURTHER PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE(S) THAT CAN RESULT IN DETERIORATION OF HEALTH AND STATE OF WELL-BEING OF THE USER. THIS CASE MEETS INITIAL 30-DAY FDA REPORTABILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
541538	CVS	HEAT WRAP - ANKLE	IMD	KOBAYASHI CONSUMER PRODUCTS LLC.	CVS460681	150827	00050428129722

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention

Terms

Patient problem · 1

• Partial thickness (Second Degree) Burn

Product problems · 1

• Improper or Incorrect Procedure or Method

Source type · 1

• CONSUMER

Type of report · 1

• Initial submission