MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-26 for ADENOTOME RH4330 manufactured by V. Mueller Div., Baxter Healthcare Co..
[12934]
Slidiing part of adenotome wheich attaches to blade came loose lacerating soft palate. Two chromic stitches were required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004875 |
| MDR Report Key | 19167 |
| Date Received | 1995-01-26 |
| Date of Report | 1995-01-24 |
| Date of Event | 1995-01-19 |
| Date Added to Maude | 1995-01-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADENOTOME |
| Product Code | KBH |
| Date Received | 1995-01-26 |
| Model Number | RH4330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19090 |
| Manufacturer | V. MUELLER DIV., BAXTER HEALTHCARE CO. |
| Manufacturer Address | MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-01-26 |