MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-02-16 for AFORSUS FATIGUE RESISTANCE DEVICE SPRINT MODEL 885-100 manufactured by 3m Unitek.
[21281505]
Due to irritation from the device, patient developed an intraoral ulcer. Orthodontist prescribed salt water rinses and an antibiotic (erythromycin) for the patient. The device was removed and patient has recovered from the infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2009-00001 |
| MDR Report Key | 1315670 |
| Report Source | 05 |
| Date Received | 2009-02-16 |
| Date of Report | 2009-01-30 |
| Date of Event | 2008-08-29 |
| Date Mfgr Received | 2009-01-30 |
| Date Added to Maude | 2009-02-25 |
| 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 | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFORSUS FATIGUE RESISTANCE DEVICE SPRINT MODEL |
| Generic Name | ORTHODONTIC SPRING |
| Product Code | ECO |
| Date Received | 2009-02-16 |
| Model Number | NA |
| Catalog Number | 885-100 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US 91016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-02-16 |