MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for 3M UNITEK TRANSBOND TX ADHESIVE 712-030 manufactured by 3m Unitek Corporaion.
[77499974]
On (b)(6) 2017, 3m was notified that a (b)(6) year-old female was diagnosed with a corneal abrasion, after particles of cured 3m unitek transbond xt adhesive allegedly got into her eye during a polishing procedure after orthodontic brackets were removed. The patient experienced pain, blurred vision and a headache as a result. The eye was flushed by the orthodontic office in the employee eye wash, and the patient saw an ophthalmologist later the same day. The ophthalmologist observed particles in the patients eye and rinsed the eye to remove the particles. The patient was prescribed an antibiotic eye drop to use for 10 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2017-00002 |
| MDR Report Key | 6639138 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-06-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 TRANSBOND TX ADHESIVE |
| Generic Name | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
| Product Code | DYH |
| Date Received | 2017-06-13 |
| Catalog Number | 712-030 |
| 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 | 2017-06-13 |