MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for 3M UNITEK NITINOL CL OFIII OVOID L014 4296-518 manufactured by 3m Unitek Corporaion.
[63191249]
On november 22, 2016, 3m was notified by a dental office in (b)(6) that a (b)(6) female patient had swallowed a broken piece of a 3m unitek nitinol classic archwire on (b)(6) 2016. The orthodontic wire was placed in (b)(6) 2016. The wire was excreted in the patients stool without incident. While no injury occurred, this event is being reported because of the potential for serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2016-00005 |
| MDR Report Key | 6187909 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-10-08 |
| Date Mfgr Received | 2016-11-22 |
| Date Added to Maude | 2016-12-19 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 | 0 |
| Brand Name | 3M UNITEK NITINOL CL OFIII OVOID L014 |
| Generic Name | ORTHODONTIC WIRE |
| Product Code | DZC |
| Date Received | 2016-12-19 |
| Catalog Number | 4296-518 |
| Operator | DENTIST |
| 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. Other | 2016-12-19 |