MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-23 for WELCH-ALLYN SPECULUM REF 58601 UNK manufactured by Welch-allyn.
[18145369]
Speculums are becoming stuck in open position while inserted into vaginal canal, at times requiring 2 persons to close speculum for vaginal withdrawal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031014 |
| MDR Report Key | 511037 |
| Date Received | 2004-01-30 |
| Date of Report | 2004-01-22 |
| Date of Event | 2004-01-16 |
| Date Added to Maude | 2004-02-12 |
| 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 | 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 SPECULUM |
| Generic Name | DISPOSABLE VAGINAL SPECULUM |
| Product Code | HDF |
| Date Received | 2004-01-23 |
| Model Number | REF 58601 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 499991 |
| Manufacturer | WELCH-ALLYN |
| Manufacturer Address | * SKANEATELES FALLS NY 13153 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-30 |