MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-02-12 for MILEX MX210 manufactured by Coopersurgical, Inc..
[787903]
During a hysteroscopy-dnc, the physician attempted to remove the dilateria by pulling the string. The dilateria broke. The physician removed the pieces. The patient was prescribed antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[8091162]
Proper removal of the dilateria is to use gentle force using forceps to grasp the tip of the dilateria. The instructions for use state in two places not to pull on the string to remove - once in the warnings section and again, in the dilateria removal instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2008-00004 |
| MDR Report Key | 997616 |
| Report Source | 06 |
| Date Received | 2008-02-12 |
| Date of Report | 2008-02-12 |
| Date of Event | 2008-01-29 |
| Date Mfgr Received | 2008-01-31 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-11-05 |
| 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 |
| 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 | 2008-02-12 |
| Model Number | MX210 |
| Lot Number | 55025 |
| Device Expiration Date | 2010-08-31 |
| 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 | 995494 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-12 |