3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
Received Nov 13, 2015 · Event occurred Oct 15, 2015
Report 2110898-2015-00049 · MDR key 5221701
Device
Generic name
Respirator Surgical Mask
Manufacturer
3m Health CareModel number
N/ACatalog number
1805
Lot number
A14300501
Product problems
- Patient-Device Incompatibility
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Sore Throat
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
THIS INFORMATION WAS NOT AVAILABLE AT TIME OF INITIAL REPORT. THE SAMPLES RECEIVED WERE VISUALLY REVIEWED AND NO VISUAL NON-CONFORMITIES WERE OBSERVED IN THE RESPIRATOR SAMPLES. THE LOT RECORDS FOR LOT A14300501 WERE REQUESTED FROM THE MANUFACTURING FACILITY. THESE RECORDS WERE REVIEWED AND ALL THE CORRECT COMPONENTS WERE USED AND ALL TESTING WAS COMPLETED AND WITHIN SPECIFICATION FOR THIS LOT. IN ADDITION, THE PROCESSING AIDS THAT COULD CONTACT THE RESPIRATORS DURING MANUFACTURE WERE REVIEWED AND HAD NOT CHANGED IN THE 5 MONTHS BEFORE THE AFFECTED PRODUCT WAS MANUFACTURED AND THE CLEANING PROCEDURES FOR THE MANUFACTURING EQUIPMENT HAD NOT CHANGED IN OVER A YEAR. THERE ARE 3 COMPLAINTS FOR THE APPLICABLE CATALOG NUMBER IN THE PAST TWO YEARS, INCLUDING THIS COMPLAINT. THE THREE COMPLAINTS ARE FOR THREE SEPARATE EVENTS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED SINCE THE PRODUCT WAS LAUNCH IN 2013.
Description of Event or Problem
ADDITIONAL INFORMATION. THE NURSE HAD UNSPECIFIED ACID REFLUX ISSUES ONGOING AT THE TIME IN OCTOBER. SHE ALLEGED SEVERE BURNING AND SORENESS IN THE THROAT ALMOST IMMEDIATELY AFTER DONNING THE MASK. SHE ALLEGED SHORTNESS OF BREATH. THE NURSE USED HER ASTHMA INHALER AND WAS ADMITTED TO THE HOSPITAL WHERE SHE WAS GIVEN UNSPECIFIED BREATHING TREATMENTS. THE NURSE ALLEGED THE SORE THROAT PERSISTED FOR SEVERAL DAYS. AS BEFORE, THE NURSE STATED THAT SHE HAD ACID REFLUX ISSUES ONGOING AT THE TIME OF THE SORE THROAT.
Additional Manufacturer Narrative
INFORMATION WAS NOT PROVIDED AFTER ATTEMPTING TO OBTAIN MORE INFORMATION. IT WAS NOTED THAT THE DEVICE WILL BE RETURNED BUT AS OF THE DATE OF THIS REPORT SUBMISSION THE DEVICE HAS NOT BEEN RETURNED.
Description of Event or Problem
A FEMALE NURSE IN THE HOSPITAL INTENSIVE CARE UNIT ALLEGED A SORE THROAT AND DIFFICULT BREATHING WITHIN 24 HOURS OF DONNING A MODEL 1805 V-FLEX(TM) PARTICULATE RESPIRATOR AND SURGICAL MASK. THE NURSE WAS ADMITTED TO THE HOSPITAL FOR UNSPECIFIED MEDICAL TREATMENT. THE NURSE HAS A HISTORY OF ASTHMA.