MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for PATTERSON SALIVA EJECTOR W/ WHITE TIP SUCTION CATHETER 089-4097 manufactured by Patterson Dental / Patterson Company Inc..
[127073593]
The tip of the catheter came off while suctioning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081182 |
| MDR Report Key | 8064827 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-10-18 |
| Date Added to Maude | 2018-11-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PATTERSON SALIVA EJECTOR W/ WHITE TIP SUCTION CATHETER |
| Generic Name | MOUTH PIECE SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2018-11-09 |
| Model Number | 089-4097 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PATTERSON DENTAL / PATTERSON COMPANY INC. |
| Manufacturer Address | 1031 MENDOTA HEIGHTS RD ST. PAUL MN 55201 US 55201 |
| Brand Name | PATTERSON SALIVA EJECTOR W/ WHITE TIP SUCTION CATHETER |
| Generic Name | MOUTH PIECE SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2018-11-09 |
| Model Number | 089-4097 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PATTERSON ENTAL / PATTERSON COMPANY INC. |
| Manufacturer Address | 1031 MENDOTA HEIGHTS RD ST. PAUL MN 55201 US 55201 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-09 |