MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-23 for WELCH ALLYN SMALL SPECULUM * manufactured by Welch-allyn, Inc..
[21707442]
When speculum was opened it popped open and caused splash back into rnp's face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028873 |
| MDR Report Key | 469532 |
| Date Received | 2003-06-23 |
| Date of Report | 2003-06-20 |
| Date of Event | 2003-06-19 |
| Date Added to Maude | 2003-07-07 |
| 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 | WELCH ALLYN SMALL SPECULUM |
| Generic Name | SPECULUM |
| Product Code | HDF |
| Date Received | 2003-06-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | MARCH 17, 2003-20 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 458397 |
| Manufacturer | WELCH-ALLYN, INC. |
| Manufacturer Address | STATE STREET ROAD SKANEATELES FALLS NY 131530220 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-06-23 |