MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-12 for FORSUS FATIGUE RESISTANT DEVICE SPRING MODULE 885-100 manufactured by 3m Unitek.
[15490855]
Due to irritation from device, pt developed an intraoral ulcer became infected. Per orthodontist, an emergency room physician prescribed an antibiotic (amoxicillin) for the infection and orthodontist prescribed mary's magic mouthwash. Orthodontist stated that the intraoral ulcer and infection had completely resolved within a couble weeks and that pt has continued with the orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2006-00004 |
| MDR Report Key | 714408 |
| Report Source | 05 |
| Date Received | 2006-05-12 |
| Date of Report | 2006-04-28 |
| Date of Event | 2006-01-17 |
| Date Mfgr Received | 2006-04-28 |
| Date Added to Maude | 2006-05-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 S PECK RD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORSUS FATIGUE RESISTANT DEVICE SPRING MODULE |
| Generic Name | ORTHODONTIC SPRING |
| Product Code | ECO |
| Date Received | 2006-05-12 |
| Model Number | NA |
| Catalog Number | 885-100 |
| 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 | 703473 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | FORSUS FATIGUE RESISTANT DEVICE SPRING MODULE |
| Baseline Generic Name | ORTHODONTIC SPRING |
| Baseline Model No | NA |
| Baseline Catalog No | 885-100 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-05-12 |