MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-06-01 for HANKS UTER DILATOR 11/12 25-5541 manufactured by Codman & Shurtleff, Inc..
[776403]
Hospital reports that a pt underwent an ultrasound guided cervical dilation, hysteroscopy and d&c polypectomy. A hank uterine dilator size 11/12 was used during the procedure. Five days following procedure, the pt reported she removed 3 metal pieces from her vagina. Metal pieces formed a small ring. Gyn equipment was examined and a dilator size 11/12 was found to be without an o ring piece.
Patient Sequence No: 1, Text Type: D, B5
[8087183]
Codman has been informed that the device is not available for eval. A lot number has been provided, therefore, a review of the device history records will be performed. We anticipate that the review will show that the instrument conformed to all specifications prior to being released to stock. If the review notes anything otherwise a follow-up report will be filed. Trends will be monitored for this and/or similar complaints. At the present time this complaint is considered to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2006-00132 |
| MDR Report Key | 979396 |
| Report Source | 05,06 |
| Date Received | 2006-06-01 |
| Date of Event | 2006-03-24 |
| Date Mfgr Received | 2006-05-04 |
| Date Added to Maude | 2008-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANKS UTER DILATOR 11/12 |
| Generic Name | DILATOR, CERVICAL, FIXED SIZE |
| Product Code | HDQ |
| Date Received | 2006-06-01 |
| Model Number | NA |
| Catalog Number | 25-5541 |
| Lot Number | 023 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 947095 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-01 |