MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-02 for PEDO PEARLS * manufactured by Pedo Pearls.
[335223]
Crowns have shown excessive rapid wear requiring replacement with less than 90 days of service. This has happened with several pts. Have so far traced back to may 2003, crowns used 1 year ago are fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032002 |
| MDR Report Key | 526247 |
| Date Received | 2003-10-02 |
| Date of Report | 2003-09-01 |
| Date of Event | 2003-07-01 |
| Date Added to Maude | 2004-05-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDO PEARLS |
| Generic Name | DENTAL PEDIATRIC CROWNS |
| Product Code | ELZ |
| Date Received | 2003-10-02 |
| Returned To Mfg | 2003-09-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 515401 |
| Manufacturer | PEDO PEARLS |
| Manufacturer Address | P.O. BOX 1215 MERLIN OR * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-10-02 |