MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-26 for HEGAR UTERINE DILATOR, DOUBLE-ENDED, 7 1/2", SIZES * 500-205 manufactured by Unk.
[20990256]
An adverse event or product problem report and a request for information were received from fda on may 24, 2007. The report stated: "while performing a subtotal hysterectomy, the physician noticed that a metal post was missing from the hank dilator. An x-ray of the patient's pelvis was taken; there was no metal post seen by the radiologist. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2007-00018 |
| MDR Report Key | 888830 |
| Date Received | 2007-07-26 |
| Date of Report | 2007-06-21 |
| Date Facility Aware | 2007-05-24 |
| Report Date | 2007-06-21 |
| Date Added to Maude | 2007-08-06 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | HEGAR UTERINE DILATOR, DOUBLE-ENDED, 7 1/2", SIZES |
| Generic Name | SURGICAL INSTRUMENT |
| Product Code | HDQ |
| Date Received | 2007-07-26 |
| Model Number | * |
| Catalog Number | 500-205 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 866371 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-26 |