MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-10-31 for FRICTION - STOP ADJUSTABLE FACEBOW 320-452 manufactured by 3m Unitek.
[237138]
Orthodontist reported that while pt was asleep, the facebow broke and pt swallowed a fragment of the facebow. The pt was examined at the hosp emergency room and had a radiography to establish the position of the metal fragment. Pt was given an anti-inflammatory medication to take (the orthodontist believes it was a generic non-prescription drug). A second radiography was done in order to confirm that the wire fragment had passed through the pt's intestinal tract. No serious injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2001-00007 |
| MDR Report Key | 360157 |
| Report Source | 05 |
| Date Received | 2001-10-31 |
| Date of Report | 2001-10-04 |
| Date of Event | 2001-09-20 |
| Date Mfgr Received | 2001-10-04 |
| Date Added to Maude | 2001-11-19 |
| 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 | 0 |
| 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 | FRICTION - STOP ADJUSTABLE FACEBOW |
| Generic Name | ORTHODONTIC FACEBOW |
| Product Code | DZB |
| Date Received | 2001-10-31 |
| Returned To Mfg | 2001-10-16 |
| Model Number | NA |
| Catalog Number | 320-452 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 349325 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | FRICTION-STOP ADJUSTABLE FACEBOW |
| Baseline Generic Name | ORTHODONTIC FACEBOW |
| Baseline Catalog No | 320-452 |
| Baseline Device Family | FACEBOW |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-10-31 |