MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-03-02 for ISO-FORM CROWNS UNK manufactured by 3m Espe Dental Products Div.
[404467]
It was reported that a pt experienced anaphylactic shock that began approx 6 hrs after placement of the iso-form temporary crown. It was reported that the pt needed med intervention which included admin of antihistamine and adrenaline. At the time 3m espe ag was made aware of the incident, the pt was reported as fine, but taking medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2006-00003 |
| MDR Report Key | 681667 |
| Report Source | 05 |
| Date Received | 2006-03-02 |
| Date of Report | 2006-02-07 |
| Date of Event | 2006-02-03 |
| Date Mfgr Received | 2006-02-07 |
| Date Added to Maude | 2006-03-07 |
| 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 | 0 |
| Manufacturer Contact | CAROLYN KRAMPE |
| Manufacturer Street | 3M CTR, BLDG 260-2A-17 |
| Manufacturer City | ST. PAUL MN 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 6517361148 |
| Manufacturer G1 | 3M |
| 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 | ISO-FORM CROWNS |
| Generic Name | PREFORMED CROWNS |
| Product Code | ELZ |
| Date Received | 2006-03-02 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 670936 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS DIV |
| Manufacturer Address | 2111 MCGAW AVE IRVINE CA 92614 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2006-03-02 |