MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-27 for PATTERSON DENTAL SUPPLY * 089-4097 100/PK manufactured by Patterson Dental Supply.
[19243269]
The pt was sedated and during oral suctin the tip of the suction catheter broke in the pt's mouth resulting in decrease o2 saturation to 69%. The pt was suctioned with a yankauer and we're unable to locate the broken tip. The procedure was stopped. The sedation was reversed. The pt awake was able to expectorate the tip of the broken cath without incident. The o2 sats returned to normal and the procedure was resumed without any other complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040832 |
| MDR Report Key | 774985 |
| Date Received | 2006-10-27 |
| Date of Report | 2006-10-27 |
| Date of Event | 2006-10-24 |
| Date Added to Maude | 2006-11-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATTERSON DENTAL SUPPLY |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2006-10-27 |
| Model Number | * |
| Catalog Number | 089-4097 100/PK |
| Lot Number | 0027 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 762762 |
| Manufacturer | PATTERSON DENTAL SUPPLY |
| Manufacturer Address | * CHICAGO IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2006-10-27 |