SWAB ALCOHOL 100 BX 1200
Received Oct 10, 2020 · Event occurred Sep 18, 2020
Report 1920898-2020-01387 · MDR key 10659901
Device
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6) USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE SWAB ALCOHOL 100 BX 1200 EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER HAS ONE BOX OF ALCOHOL SWABS THAT DO NOT HAVE AN EXPIRATION DATE ON THEM. STATED THERE IS A COPYRIGHT DATE OF 2009 ON THE BOX. ADVISED CONSUMER THIS PRODUCT BOX IS EXPIRED. LOT # 1046878. CAT # 326895. DATE OF EVENT: UNKNOWN.
Additional Manufacturer Narrative
H6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS BATCH WAS MANUFACTURED IN 2011, FILES ARE ONLY RETAINED FOR 7 YEARS, THEREFORE NO DHR REVIEW CAN BE COMPLETED. H3 OTHER TEXT : SEE H10.
Description of Event or Problem
IT WAS REPORTED THAT THE SWAB ALCOHOL 100 BX 1200 EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER HAS ONE BOX OF ALCOHOL SWABS THAT DO NOT HAVE AN EXPIRATION DATE ON THEM. STATED THERE IS A COPYRIGHT DATE OF 2009 ON THE BOX. ADVISED CONSUMER THIS PRODUCT BOX IS EXPIRED. LOT # 1046878, CAT # 326895, DATE OF EVENT: UNKNOWN.