MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-19 for 3M UNITEK INCOGNITO APPLIANCE SYSTEM 358-110 manufactured by 3m Unitek Corporaion.
[75598567]
There have been no other events of this nature reported to 3m for this product. The instructions for use state that the patient should be notified to contact their orthodontist about broken archwires or lost brackets immediately.
Patient Sequence No: 1, Text Type: N, H10
[75598568]
On (b)(6) 2017, 3m was notified by an orthodontist that a (b)(6) male patient had swallowed a broken wire fragment of the 3m unitek incognito appliance system. The piece of wire was removed endoscopically (date unknown). According to the orthodontist there are no long-term consequences expected and the patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2017-00001 |
| MDR Report Key | 6580133 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-19 |
| Date of Report | 2017-02-14 |
| Date Mfgr Received | 2017-02-14 |
| Date Added to Maude | 2017-05-19 |
| 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 | 3 |
| Manufacturer Contact | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M UNITEK |
| Manufacturer Street | 2724 SOUTH PECK RD. |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 910165097 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M UNITEK INCOGNITO APPLIANCE SYSTEM |
| Generic Name | ORTHODONTIC WIRE |
| Product Code | DZC |
| Date Received | 2017-05-19 |
| Catalog Number | 358-110 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK CORPORAION |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 910165097 US 910165097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-19 |