MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for ALGINATE BASIS 776-2102 manufactured by Ormco Corporation.
[139827343]
It was alleged that a piece of metal was found in a 25lb. Bag of alginate. There was no serious injury associated with this incident.
Patient Sequence No: 1, Text Type: N, H10
[139827344]
Customer found a metal piece in their alginate upon opening the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2019-00005 |
| MDR Report Key | 8333197 |
| Date Received | 2019-02-12 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-01-18 |
| Date Added to Maude | 2019-02-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1889 W. MISSION BLVD |
| Manufacturer City | POMONA CA 91766 |
| Manufacturer Country | US |
| Manufacturer Postal | 91766 |
| Manufacturer Phone | 9096713431 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 1889 W. MISSION BLVD |
| Manufacturer City | POMONA CA 91766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALGINATE BASIS |
| Generic Name | MATERIAL IMPRESSION |
| Product Code | ELW |
| Date Received | 2019-02-12 |
| Catalog Number | 776-2102 |
| Lot Number | 6880196 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1889 W. MISSION BLVD POMONA CA 91766 US 91766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-12 |