MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-03-13 for TRANSBOND XT ETCHING GEL SYRINGE 712-039 manufactured by 3m Unitek.
[18602796]
Orthodontist's office reported that while etching pt's teeth for orthodontic treatment, etching gel escaped from a crack in the syringe into pt's eye. Pt's eye was rinsed with water for 15 minutes after incident. The next day pt was taken to an ophthalmologist who prescribed ophthalmic antibiotics. The pt's parents reported that he is still experiencing some blurriness in the eye. The ophthalmologist advised pt's parents that it might take up to a year for the eye to fully heal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2006-00002 |
| MDR Report Key | 687120 |
| Report Source | 05 |
| Date Received | 2006-03-13 |
| Date of Report | 2006-02-27 |
| Date of Event | 2006-01-10 |
| Date Mfgr Received | 2006-02-27 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 2006-03-16 |
| 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 | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| 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 | TRANSBOND XT ETCHING GEL SYRINGE |
| Generic Name | ORTHODONTIC ETCHING GEL |
| Product Code | DYH |
| Date Received | 2006-03-13 |
| Model Number | NA |
| Catalog Number | 712-039 |
| Lot Number | 8KY |
| ID Number | * |
| Device Expiration Date | 2001-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 676324 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK ROAD MONROVIA CA 91016 US |
| Baseline Brand Name | TRANSBOND XT ETCHING GEL SYRINGE |
| Baseline Generic Name | PHOSPHORIC-ACID ETCHING GEL |
| Baseline Model No | NA |
| Baseline Catalog No | 712-039 |
| Baseline Device Family | APC PLUS SMARTCLIP |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K813180 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-13 |