MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-22 for TRANSBOND PLUS SELF ETCHING PRIMER 712-090 manufactured by 3m Unitek.
[301191]
Orthodontic assistant said that they were bending the applicator as they removed it from the package, which resulted in a spring action of the applicator so that some of the primer flew into their right eye. (they were not wearing safety glasses). They immediately rinsed their eye with large amounts of water. Orthodontic assistant stated that a physician prescribed blephamide (a topical anti-inflammatory/anti-infective which is indicated when the risk of superficial ocular infection is high) for their eye. Orthodontic assistant said that their eye feels fine and there are no after-effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2003-00003 |
| MDR Report Key | 479534 |
| Date Received | 2003-08-22 |
| Date of Report | 2003-08-12 |
| Date of Event | 2003-08-12 |
| Date Mfgr Received | 2003-08-12 |
| Date Added to Maude | 2003-08-26 |
| 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 S PECK RD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Manufacturer G1 | 3M UNITEK |
| Manufacturer Street | 2724 SOUTH PECK RD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSBOND PLUS SELF ETCHING PRIMER |
| Generic Name | ORTHODONTIC PRIMER |
| Product Code | DYH |
| Date Received | 2003-08-22 |
| Model Number | NA |
| Catalog Number | 712-090 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 468375 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD MONROVIA CA 91016 US |
| Baseline Brand Name | TRANSBOND PLUS SELF ETCHING PRIMER |
| Baseline Generic Name | ORTHODONTIC PRIMER |
| Baseline Model No | NA |
| Baseline Catalog No | 712-090 |
| Baseline Device Family | ORTHODONTIC PRIMER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K001494 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-08-22 |