MalfunctionNTO
GUM PERIOSHIELD ORAL HEALTH RINSE
Received Jun 17, 2021 · Event occurred Jun 15, 2021
Report MW5101973 · MDR key 12032199
Device
Generic name
Rinse, Oral, Antibacterial (by Physical Means)
Catalog number
1775R
Lot number
01A
Product problems
- Contamination
Patient
55 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
AN URGENT RECALL MEDICAL DEVICE RECALL WAS ISSUED. I, THE CUSTOMER WAS NOTIFIED BY (B)(6) ON (B)(6) 2021. THE REASON FOR THE RECALL STATED IN THE LETTER WAS THAT THE PRODUCT COULD HAVE BEEN CONTAMINATED WITH MICRO-ORGANISMS BURKHOLDERIA CEPACIA AND/OR BURKHOLDERIA CONTAMINANTS. I HAVE NOT USED THE PRODUCT SINCE AROUND (B)(6) 2021. FDA SAFETY REPORT ID # (B)(4).