MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-07 for HANK DILATOR 500205 NONE manufactured by Jarret.
[598620]
+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 | 843532 |
| MDR Report Key | 843532 |
| Date Received | 2006-07-07 |
| Date of Report | 2006-07-07 |
| Date of Event | 2006-06-27 |
| Report Date | 2006-07-07 |
| Date Reported to FDA | 2006-07-07 |
| Date Added to Maude | 2007-05-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | HANK DILATOR |
| Generic Name | DILATOR |
| Product Code | HDQ |
| Date Received | 2006-07-07 |
| Model Number | 500205 |
| Catalog Number | NONE |
| Lot Number | NONE |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 830662 |
| Manufacturer | JARRET |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-07 |