GRACEY CURETTE
Received Apr 22, 2019 · Event occurred Mar 27, 2019
Report 1416605-2019-00007 · MDR key 8535976
Device
Generic name
Curette, Periodontic
Manufacturer
Hu-friedy Mfg. Co. LlcModel number
SG13/149E2Catalog number
SG13/149E2
Lot number
615
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
PATIENT AGE, WEIGHT, ETHNICITY AND RACE UNKNOWN. BASED ON THE LOT NUMBER OF THE DEVICE, THIS DEVICE WAS PRODUCED PRIOR TO THE UDI DEADLINE FOR CLASS 1 DEVICES, THEREFORE UDI IS NOT PRESENT. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. NO KNOWN CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES.
Description of Event or Problem
WHILE THE HYGIENIST WAS SCALING WITH SG13/149E2, THE TIP BROKE OFF THE INSTRUMENT. IT WAS BELIEVED THAT THE PATIENT SWALLOWED THE TIP. PATIENT WAS SENT TO AN OUTPATIENT IMAGING CENTER FOR AN X-RAY. NO FOLLOW UP WAS REPORTED AT THIS TIME.