MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-02 for * 25-5541 manufactured by Codman.
[470567]
Pt underwent a ultrasound guided cervical dilatation hysteroscopy and d&c polypectomy. A hank uterine dilator gauge 11/12 was used during the procedure. Five days following procedure, pt reported she removed 3 metal pieces from her vagina. Metal pieces formed a small ring. Gyn equipment examimed. A dilator size 11/12 was found to be without o ring piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038953 |
| MDR Report Key | 716629 |
| Date Received | 2006-05-02 |
| Date of Report | 2006-04-18 |
| Date of Event | 2006-03-24 |
| Date Added to Maude | 2006-05-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | DILATOR SIZE 11/12 |
| Product Code | HDQ |
| Date Received | 2006-05-02 |
| Model Number | * |
| Catalog Number | 25-5541 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 705697 |
| Manufacturer | CODMAN |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-02 |