MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-09-07 for TRANSBOND XT PRIMER, REF 712-034 manufactured by .
[727566]
In preparation for orthodontic treatment. A stomatologist injected a dental anesthetic intraorally into a patient before making an incision in the gum in order to expose an undergum cuspid tooth. Approximately five minutes following the oral surgery, the orthodontist applied orthodontic etching gel, orthodontic primer, and orthodontic adhesive with attachment to the patient's tooth. The first preparation of the tooth was not adequate, so the orthodontist re-prepared the tooth. The treatment was initially uneventful; however, the patient started to express distress and shortly thereafter cardiac arrest occurred. Subsequent attempts to revive the patient were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[7808405]
It is not clear what orthodontic devices were used in this event, since the orthodontist has not provided this information to 3m. However, 3m unitek has determined that the following devices were shipped to the orthodontist in 2006 and 2007. Transbond xt primer, lot #s 5cj, 6cx, 6eb; transbond xt etching gel, lot # 6he; transbond plus self etching primer, lot # 266707; transbond xt adhesive in capsules, lot #s ph, rk, wn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2007-00003 |
| MDR Report Key | 908656 |
| Report Source | 05 |
| Date Received | 2007-09-07 |
| Date of Report | 2007-08-27 |
| Date of Event | 2007-08-27 |
| Date Mfgr Received | 2007-08-27 |
| Date Added to Maude | 2008-01-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARYLN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSBOND XT PRIMER, |
| Generic Name | NONE |
| Product Code | DYH |
| Date Received | 2007-09-07 |
| Catalog Number | REF 712-034 |
| Lot Number | 5CJ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 944412 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-09-07 |