MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-12-20 for MILEX MXPEC * manufactured by Coopersurgical, Inc..
[17802164]
Patient has been fit for a cube pessary. The pt was instructed by their physician to leave the pessary in place until their next appointment in 02/2005. The pt developed a urinary tract infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2004-00025 |
| MDR Report Key | 561116 |
| Report Source | 04 |
| Date Received | 2004-12-20 |
| Date of Report | 2004-11-20 |
| Date Mfgr Received | 2004-11-22 |
| Date Added to Maude | 2004-12-27 |
| 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 | 3 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILEX |
| Generic Name | CUBE PESSARY |
| Product Code | HDW |
| Date Received | 2004-12-20 |
| Model Number | MXPEC |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 550823 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | * TRUMBULL CT * US |
| Baseline Brand Name | MILEX |
| Baseline Generic Name | CUBE PESSARY |
| Baseline Model No | MXPEC |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-12-20 |