MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-07-20 for MILEX MX220 manufactured by Coopersurgical, Inc..
[678761]
While attempting to remove the dilateria from the pt, the string broke. The physician tried to remove it by pulling the plastic end which broke off. Forceps and a hysteroscope were used to remove fragments from the pt.
Patient Sequence No: 1, Text Type: D, B5
[7980741]
The string breaking during removal is consistent with using the string as a means of removal. The instructions for use in two different sections cautions against pulling on the string to remove.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2007-00016 |
| MDR Report Key | 883062 |
| Report Source | 05 |
| Date Received | 2007-07-20 |
| Date of Report | 2007-07-19 |
| Date of Event | 2007-06-27 |
| Date Mfgr Received | 2007-07-05 |
| Date Added to Maude | 2007-09-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILEX |
| Generic Name | DILATERIA |
| Product Code | HDY |
| Date Received | 2007-07-20 |
| Model Number | MX220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 864774 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-07-20 |