D
Patient 1
BURN LEG, BURN HOLE IN LEG/SECOND DEGREE BURN [BURNS SECOND DEGREE]. CELLULITIS [CELLULITIS]. CHEMICAL BURN [CAUSTIC INJURY]. BURNED A HOLE IN LEG (SKIN) [SKIN INJURY]. BLISTERS LEG [BLISTER]. SLIGHT SCAR [SCAR]. PAIN LEG [PAIN IN EXTREMITY]. SCAB [SCAB]. CAN'T SLEEP [INSOMNIA]. UPSET [EMOTIONAL DISTRESS]. REDNESS [ERYTHEMA]. ACHILLES TENDON TENDER [TENDON PAIN]. WOUND CULTURE POSITIVE FOR STAPHYLOCOCCUS AUREUS [STAPHYLOCOCCAL INFECTION]. ABSCESS FORMATION [ABSCESS]. SKIN SWOLLEN [SKIN SWELLING]. WOUND DRAINAGE [WOUND DRAINAGE]. NECROTIC SKIN [SKIN NECROSIS]. SOME OF THE CONTENTS CAME OUT OF THE HEAT DISCS [PRODUCT QUALITY ISSUE]. USED A BACK WRAP ON HIS LEG [DEVICE MISUSE]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A MALE AGE UNSPECIFIED, USED THERMACARE PAIN RELIEVING HEATWRAPS, BACK, SIZE UNK 1 APPLICATION APPLIED TO HIS BACK, UNSPECIFIED FREQUENCY FOR 1 DAY IN LATE 2006 AND THE WRAP MUST HAVE BROKEN OPEN AND SOME OF THE CONTENTS OF THE HEAT DISCS CAME OUT AND DRIPPED ONTO THE BACK OF HIS LEG. THE AREA BURNED AND BLISTERED AND HE THOUGHT IT COULD BE INFECTED. THE CONSUMER REPORTED THAT HE WAS APPLYING VASELINE TO THE AREA AND IT WAS STARTING TO SCAB; HE WAS IN A LOT OF PAIN. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY - UNK, MEDICAL HISTORY - "GOOD HEALTH". NO FURTHER INFO WAS PROVIDED. EIGHT DAYS LATER, DRUG AND POISON INFO CTR F/U PHONE CALL: THE CONSUMER REPORTED THAT HE WAS NOT DOING WELL AND HE WAS GOING TO THE EMERGENCY DEPT NOW. HE REPORTED THAT HE CANNOT SLEEP AND HE CANNOT WORK. NO FURTHER INFO WAS PROVIDED. THE NEXT DAY, RECEIVED CONSUMER'S F/U PHONE CALL: THE CONSUMER REPORTED THAT ONE OF THE GEL CAPSULES OF THE THERMACARE LEAKED OUT ONTO ONE OF HIS LEGS AND HE WAS BURNT. HE REPORTED THAT HE WENT TO THE HOSP TWO DAYS PRIOR AND HE HAD AN INFECTION AND A CHEMICAL BURN; HE WAS EXPERIENCING EXCRUCIATING PAIN AND HE WAS UPSET BY THE EXPERIENCE. HE MENTIONED THAT HE WAS OUT OF WORK FOR TWO WEEKS. NO FURTHER INFO WAS PROVIDED. THREE DAYS LATER, RECEIVED CONSUMER'S F/U PHONE CALL: "THE CONSUMER REPORTED THAT HE HAD A BURN ON HIS FROM THE THERMACARE WRAP; HE HAD AN INFECTION NOW AND HAD NOT TREATED THE INFECTION WITH ANTIBIOTICS." NO FURTHER INFO WAS PROVIDED. THE SAME DAY RECEIVED CONSUMER'S F/U PHONE CALL: THE CONSUMER REPORTED THAT HE WAS HEALING. NO FURTHER INFO WAS PROVIDED. FIVE DAYS LATER, RECEIVED CONSUMER'S F/U PHONE CALL: THE CONSUMER REPORTED THAT HE SPENT A WEEK IN THE HOSP BECAUSE OF HIS EXPERIENCE WITH THERMACARE AND WHILE THERE HE WAS GETTING HIS LEG ALL CUT OPEN. THE CONSUMER MENTIONED THAT HE MISSED TWO TO THREE WEEKS OF WORK. NO FURTHER INFO WAS PROVIDED. ON 11-DEC-2006 REVIEW OF DATA BASE ON 11-DEC-2006 REVEALED CONSUMER'S INITIAL CALL. CONSUMER HUNG UP WHEN ASKED FOR ADDITIONAL INFO FOR HEALTH AND SAFETY: THE CONSUMER REPORTED THAT HE USED THERMACARE BACK WRAP ON HIS LEG AND IT BURNED A HOLE IN HIS LEG A WEEK AGO. HE REPORTED THAT HE THOUGHT SOME OF THE GEL CAME OUT OF THE PRODUCT. THE CONSUMER DISCONTINUED USE OF THE PRODUCT. NO FURTHER INFO WAS PROVIDED. ON 08-APR-2008 RECEIVED ATTORNEY'S F/U LETTER: AN ATTORNEY REPORTED THAT THE CONSUMER SUSTAINED INJURIES AS A RESULT OF A DEFECTIVE THERMACARE HEATWRAP PRODUCT AND SUFFERED A BURN INJURY WHICH BECAME INFECTED AND ULTIMATELY REQUIRED SURGERY. NO FURTHER INFO WAS PROVIDED. ON 02-JUN-2009 RECEIVED ATTORNEY'S F/U LETTER AND PT'S HEALTH CARE QUESTIONAIRE: INFO FROM AN ATTORNEY AND A QUESTIONAIRE REVEALED THAT THE PT HAD SECOND DEGREE BURNS, CELLULITIS AND STILL HAD A SLIGHT SCAR. PT DEMOGRAPHIC INFO PROVIDED SHOWED THE PT WAS A MALE. IT WAS REPORTED THAT THE PT APPLIED THE WRAP ON APPROXIMATELY THE DAY PRIOR TO ORIGINAL DATE, WHEN HE WENT TO BED, AND REMOVED IT WHEN HE WOKE UP THE FOLLOWING MORNING. THE PT WORE THE WRAP FOR APPROXIMATELY 8 HRS. THE PT SLEPT WITH THE WRAP ON AND WAS LYING ON TOP OF THE WRAP DURING THE NIGHT. WHEN HE AWOKE, HE NOTICED THE BLISTER. DUE TO HIS DIABETES, THE PT DISCUSSED THE USE OF THE HEATWRAP WITH HIS PHYSICIAN AND THE PT WAS INSTRUCTED TO WEAR SOMETHING BETWEEN THE WRAP AND HIS SKIN. THE PT DID NOT CHECK THE SKIN UNDER THE PRODUCT BECAUSE HE WAS SLEEPING. ADDITIONALLY, IT WAS REPORTED THAT THE PT HAD USED THE HEATWRAP ON SEVERAL OCCASIONS IN THE PAST. THE QUESTIONNAIRE NOTED THAT THE PT'S OVERALL SKIN CONDITION WAS NORMAL, HIS SKIN TONE WAS VERY LIGHT/FAIR AND THAT HIS SKIN BURNS MODERATELY. IT ALSO NOTED THAT THE PT DENIED HAVING SENSITIVE SKIN AND DENIED PERSPIRING WHILE USING THE PRODUCT. ON 22-JUN-2009 RECEIVED MEDICAL RECORDS FROM EMERGENCY ROOM AND HOSP ADMISSION: ON EIGHT DAYS AFTER THE ORIGINAL DATE, THE PT WAS SEEN IN THE EMERGENCY ROOM (ER) DUE TO A CHEMICAL BURN ON HIS RIGHT LOWER LEG. UPON PRESENTATION TO THE ER, THE PT'S SKIN WAS NOTED TO BE RED, SWOLLEN, PAINFUL, AND DRAINING. THE PT REPORTED THAT HE NOTICED DRAINAGE SEVERAL DAYS PRIOR TO VISITING THE ER. SINCE THEN, HE HAD CLEANED THE WOUND DAILY WITH PEROXIDE AND TREATED IT WITH BACITR...