MAUDE MDR 745899

MDR report key
745899
Report number
9616096-2006-00036
Event key
0
Event type
3
Date of event
2006-06-29
Date received
2006-08-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHERYL SANZARE
Address
1400 HOLCOMB BRIDGE RD ROSWELL GA 30076 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KIMBERLY-CLARK ANTI-FOG SURGICAL MASKMASK, SURGICALKIMBERLY-CLARK CORP.FXXNA49235UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-08-0901. R

Event Narratives#

D

Patient 1

IN 2006, A CUSTOMER INFORMED KIMBERLY-CLARK PIQ OF AN INCIDENT INVOLVING A NURSE WHO EXPERIENCED AN ANAPHYLACTIC REACTION WHILE WEARING THE KIMBERLY-CLARK ANTI-FOG SURGICAL MASK. ON JULY 18, 2006, THE DR WHO TREATED THE NURSE CALLED KIMBERLY-CLARK PIQ AND ASKED TO SPEAK WITH THE PRODUCT SAFETY GROUP TO OBTAIN MORE INFO ABOUT THE PRODUCT. THE DR REPORTED THAT HE TREATED THE NURSE, BUT PROVIDED NO DETAILS ABOUT THE TREATMENT OTHER THAN TO SAY THAT THE PT'S CONDITION IMPROVED AND "SHE IS FINE". HE ALSO COMMENTED THAT THIS HER SECOND REACTION WHILE WEARING THE MASK. ON THE FOLLOWING DAY, KIMBERLY-CLARK PRODUCT SAFETY PROVIDED THE DR WITH A LIST OF INGREDIENTS IN THE MASK SO AS TO IDENTIFY THE POSSIBLE OFFENDING SUBSTANCE. IN A F/U EMAIL ON JULY 20, 2006, PRODUCT SAFETY PROVIDED THE DR WITH A REVIEW OF THE COMPLAINT HISTORY WHICH DOCUMENTED A VERY LOW LEVEL OF MEDICAL INCIDENTS REPORTED FOR THIS MASK AND SUGGESTED THE POSSIBILITY OF AN IDIOSYNCRATIC REACTION.