SWAB ALCOHOL 100 BX 1200
Received Oct 10, 2020 · Event occurred Sep 18, 2020
Report 1920898-2020-01388 · MDR key 10659907
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. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SWAB ALCOHOL 100 BX 1200 EXPERIENCED NO LABEL/MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER WANTED TO KNOW IF ALCOHOL SWABS WERE GOOD TO USE. STATED, SWABS WERE DONATED TO FACILITY. LOT: 9238170. CATALOG: 326895. TRADEMARK: 2003.
Additional Manufacturer Narrative
H.6. 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 2009, FILES ARE ONLY RETAINED FOR 7 YEARS, THEREFORE NO DHR REVIEW CAN BE COMPLETED. H3 OTHER TEXT : SEE H.10.
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SWAB ALCOHOL 100 BX 1200 EXPERIENCED NO LABEL/MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER WANTED TO KNOW IF ALCOHOL SWABS WERE GOOD TO USE. STATED, SWABS WERE DONATED TO FACILITY. LOT: 9238170. CATALOG: 326895. TRADEMARK: 2003.