MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-06-25 for TRANSBOND PLUS SELF ETCHING PRIMER 712-090 manufactured by 3m Unitek.
[337276]
Pt experienced injury to the gums near the lower left cuspid when inadvertent contact of transbond plus self etching primer to this area occurred. Orthodontist stated that although the affected area was carefully rinsed after the contact with the transbond plus self etching primer, an examination a week later revealed gingival necrosis and the gum tissue sloughing off to the point at which some tooth root was exposed. Pt has consulted with a dentist who plans to do a gingival graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2004-00005 |
| MDR Report Key | 531551 |
| Report Source | 05 |
| Date Received | 2004-06-25 |
| Date of Report | 2004-06-14 |
| Date of Event | 2004-06-01 |
| Date Mfgr Received | 2004-06-14 |
| Date Added to Maude | 2004-06-29 |
| 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 PLUS SELF ETCHING PRIMER |
| Generic Name | ORTHODONTIC PRIMER |
| Product Code | DYH |
| Date Received | 2004-06-25 |
| Model Number | NA |
| Catalog Number | 712-090 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 520796 |
| 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 | 2004-06-25 |