TYPENEX RECIPIENT IDENTIFICATION BAND, RED
Received Nov 15, 2000 · Event occurred Oct 16, 2000
Report 9612051-2000-00018 · MDR key 305585
Device
Generic name
Typenex Recipient Identification Band, Red
Manufacturer
Baxter Healthcare Corp.Model number
NACatalog number
4R4608
Lot number
A00G19054
Product problems
- Reaction
Patient
34 YR
- Blister(s)
- Erythema
- Rash
- Swelling
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
BAXTER RECEIVED NOTIFICATION OF AN ALLEGED ALLERGIC REACTION ASSOCIATED WITH THE TYPENEX BLOOD RECIPIENT IDENTIFICATION BAND. THIS BAND DOES NOT CONTAIN NATURAL RUBBER LATEX, HOWEVER, DURING THE COURSE OF THIS INVESTIGATION, IT WAS IDENTIFIED THAT THE BAND DOES CONTAIN ACRYLIC LATEX. BAXTER CONTACTED THE OCCUPATIONAL HEALTH REPRESENTATIVE FOR THE CUSTOMER. AT THIS TIME, THE CO BECAME AWARE THAT THE PT WAS AN EMPLOYEE UNDERGOING TRAINING AT THIS FACILITY. THE EMPLOYEE VOLUNTEERED TO ROLE-PLAY THE PT DURING A TRAINING ORIENTATION. THE EMPLOYEE DEVELOPED THE FOLLOWING SYMPTOMS AFTER THE IDENTIFICATION BAND HAD BEEN APPLIED TO THE EMPLOYEE'S WRIST. WITHIN TWO MINUTES THE EMPLOYEE'S WRIST BECAME RED AND SWOLLEN. APPROXIMATELY ONE MINUTES LATER, THE EMPLOYEE VOMITED. 50 MG OF BENADRYL WAS ADMINISTERED TO THE EMPLOYEE. THE EMPLOYEE'S CONDITION DID NOT IMPROVE. THE EMPLOYEE WAS TAKEN TO THE EMERGENCY ROOM. AT THE ER, THE EMPLOYEE RECEIVED IV BENADRYL AND IV STEROIDS. A BLISTER FORMED ON THE EMPLOYEE'S WRIST AND A RASH DEVELOPED ON THE ARM UP TO THE ELBOW. EMPLOYEE REFERRED TO AN ALLERGIST. AT THIS TIME EMPLOYEE RECEIVED PREDNISONE AND BENADRYL. THE EMPLOYEE FELT WELL AND WENT HOME. THE NEXT DAY, THE SYMPTOMS REAPPEARED. EMPLOYEE WENT TO THE ER AND GIVEN BENADRYL. EMPLOYEE'S CONDITION IMPROVED AND WAS RELEASED. ALLERGIST BELIEVES THE EMPLOYEE'S SYMPTOMS ARE NOT RELATED TO THE TYPENEX BAND AS THE SYMPTOMS CONTINUE TO REOCCUR. THE EMPLOYEE RETURNED TO WORK AND DEVELOPED SIMILAR SYMPTOMS WHILE WORKING WITH ACETATE PAPER. ALLERGIST CONFIRMED PATCH TESTING FOR LATEX TO BE NEGATIVE. EMPLOYEE HAS NO KNOWN ALLERGIES. ALLERGIST BELIEVES THE EMPLOYEE IS REACTING TO SOMETHING ELSE. BAXTER PROVIDED THE MATERIAL SAFETY DATA SHEET FOR THE COMPONENTS OF THE TYPENEX IDENTIFICATION BAND TO THE ALLERGIST TO ASSIST IN THE INVESTIGATION. AT THIS TIME THE EMPLOYEE CONTINUES TO SEE THE ALLERGIST FOR FURTHER EVAL OF THE REOCCURRING SYMPTOMS.