MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-04-03 for FORSUS FATIGUE RESISTANT DEVICE WITH DIRECT PUSH ROD 885-121 manufactured by 3m Unitek.
[18949524]
Orthodontist reported that due to irritation from device, pt developed an intraoral ulcer which became infected. A physician at an urgent care center prescribed an antibiotic (erthromycin) to pt for the infection. Orthodontist removed the device from pt's mouth and the ulcer has healed completely. Orthodontist reported that pt is doing fine and has continued with orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2002-00002 |
| MDR Report Key | 386955 |
| Report Source | 05 |
| Date Received | 2002-04-03 |
| Date of Report | 2002-03-08 |
| Date of Event | 2002-03-01 |
| Date Mfgr Received | 2002-03-08 |
| Date Added to Maude | 2002-04-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH 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 WITH DIRECT PUSH ROD |
| Generic Name | ORTHODONTIC SPRING |
| Product Code | ECO |
| Date Received | 2002-04-03 |
| Model Number | NA |
| Catalog Number | 885-121 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 375982 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK ROAD MONROVIA CA 91016 US |
| Baseline Brand Name | FORSUS FATIGUE RESISTANT DEVICE WITH DIRECT PUSH ROD |
| Baseline Generic Name | ORTHODONTIC SPRING |
| Baseline Model No | NA |
| Baseline Catalog No | 885-121 |
| Baseline Device Family | FORSUS FATIGUE RESISTANT DEVICE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-04-03 |