MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-14 for 3M ESPE STAINLESS STEEL CROWN, PRIMARY MOLAR ND- 96 ND-96 manufactured by 3m Espe Dental Products.
[21103982]
On (b)(6) 2012, it was reported to 3m espe that a child was hospitalized after the child had received dental treatment, which included a 3m(tm) espe(tm) primary stainless steel crown (molar). The placement of the crown took place on (b)(6) 2012. Following placement of the crown, the child developed a fever and chills. In addition, the palate was inflamed with white spots. The child was taken to a hospital for treatment, details of which were not made available to 3m espe. The tests for the cause of this reaction are ongoing; the child's condition is reported as recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2013-00001 |
| MDR Report Key | 2919726 |
| Report Source | 05 |
| Date Received | 2013-01-14 |
| Date of Report | 2012-12-14 |
| Date of Event | 2012-08-22 |
| Date Mfgr Received | 2012-12-14 |
| Date Added to Maude | 2013-01-18 |
| 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 CTR BLD 275-2W-08 |
| Manufacturer City | ST PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Street | 2111 MCGAW AVE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE STAINLESS STEEL CROWN, PRIMARY MOLAR |
| Generic Name | CROWN, PREFORMED |
| Product Code | ELZ |
| Date Received | 2013-01-14 |
| Model Number | ND- 96 |
| Catalog Number | ND-96 |
| 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 55144100 US 55144 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-01-14 |