MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-06-11 for CONDOM CATHETER 37000 manufactured by Rusch Decatur.
[18954863]
Customer reports bubbles in condom which causes blockage and leakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045162-2001-00074 |
| MDR Report Key | 338025 |
| Report Source | 04 |
| Date Received | 2001-06-11 |
| Date of Report | 2001-06-08 |
| Date Mfgr Received | 2001-05-08 |
| Date Added to Maude | 2001-06-21 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROLANDA SCOTT, QUALITY ADMIN |
| Manufacturer Street | 2450 MEADOWBROOK PARKWAY |
| Manufacturer City | DULUTH GA 30136 |
| Manufacturer Country | US |
| Manufacturer Postal | 30136 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONDOM CATHETER |
| Generic Name | UROLOGICAL |
| Product Code | EXJ |
| Date Received | 2001-06-11 |
| Model Number | NA |
| Catalog Number | 37000 |
| Lot Number | 200006, 200010 |
| ID Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 327329 |
| Manufacturer | RUSCH DECATUR |
| Manufacturer Address | 5335 DIVIDEND DRIVE DECATUR GA 30096 US |
| Baseline Brand Name | CONDOM CATHETER |
| Baseline Generic Name | UROLOGICAL |
| Baseline Model No | NA |
| Baseline Catalog No | 37000 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-06-11 |