MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-30 for ADAPT-IT UNK manufactured by Wft/aquaplast Corp..
[17036348]
A mold was made to open mouth and push tongue into a consistent position for radiation treatment. Product used was low temperature pellet, adapt-it form. The mold would not release from the pt's lower teeth. (upper released) a vacuum prevented lower teeth from releasing. Dr. Tried to release. After sometime oral surg. Was called. Pt to or to drill a hole in the mold.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 104030 |
| MDR Report Key | 104030 |
| Date Received | 1997-06-30 |
| Date of Report | 1997-01-08 |
| Date of Event | 1997-01-06 |
| Date Facility Aware | 1997-01-06 |
| Report Date | 1997-01-08 |
| Date Reported to Mfgr | 1997-01-08 |
| Date Added to Maude | 1997-07-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADAPT-IT |
| Generic Name | PELLETS TO FORM RIGID MOLD WHEN DRY |
| Product Code | BRT |
| Date Received | 1997-06-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | PHONE: 201-891-1041 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 102353 |
| Manufacturer | WFT/AQUAPLAST CORP. |
| Manufacturer Address | 30 LAWLINS PARK WYCOFF NJ 07481 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-30 |