MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-16 for LAVA C.O.S. POWDER 68960 manufactured by 3m Espe Dental Products.
[2631164]
On march 1, 2012, 3m espe was informed that on (b)(6) 2011, a (b)(6) female, pt had an intra-oral dental scan performed using 3m espe lava power for cos. Three days later, the pt noted symptoms involving her left vocal cord, which has subsequently been categorized as a paralyzed vocal cord. Based on info provided by the pt's dentist, medical professionals do not know the cause of the paralysis and feel that it may take up to one year to heal.
Patient Sequence No: 1, Text Type: D, B5
[9760334]
While the lava cos device (optical impression system) itself was exempt from filing, the 510k (k073199) included detailed info on the lava c. O. S. Powder and the purpose of the filing was to gain clearance for the powder and the powder delivery system. No other reports of any adverse health effects following use of the subject powder have been reported to 3m espe. Follow-up reports will be submitted if 3m espe becomes aware of any other info pertinent to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2012-00004 |
| MDR Report Key | 2496030 |
| Report Source | 05 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-03-01 |
| Date of Event | 2011-10-13 |
| Date Mfgr Received | 2012-03-01 |
| Date Added to Maude | 2012-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGIE DRAPER |
| Manufacturer Street | 3M CENTER BLDG 275-2W-08 |
| Manufacturer City | SAINT PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAVA C.O.S. POWDER |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | NOF |
| Date Received | 2012-03-16 |
| Catalog Number | 68960 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | SAINT PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2012-03-16 |