MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for ALGINATE BASIS, CINNAMON, 25LB 7762102 manufactured by Ormco Corporation.
[141727257]
It was alleged that the patient was injured on the hand when dispensing basis alginate, cinnamon, 776-2102, lot 6919261, prior to mixing.
Patient Sequence No: 1, Text Type: N, H10
[141727258]
Metal shaving was found in the bag of alginate, 776-2102, lot 6919261, and the dental associate was cut on the hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2019-00008 |
| MDR Report Key | 8506531 |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2018-09-25 |
| Date Added to Maude | 2019-04-11 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1889 WEST MISSION BLVD POMONA |
| Manufacturer City | CALIFORNIA 91766 |
| Manufacturer Country | US |
| Manufacturer Postal | 91766 |
| Manufacturer Phone | 9096713431 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 1889 WEST 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, CINNAMON, 25LB |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2019-04-11 |
| Returned To Mfg | 2019-03-28 |
| Catalog Number | 7762102 |
| Lot Number | 6919261 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1889 WEST MISSION BLVD. PAMONA CA 91766 US 91766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-11 |