MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-18 for SHERWOOD DAVIS & GECK * manufactured by Sherwood Davis & Geck.
[258808]
Rptr frustrated with persistent problem with defective product. Quality of texas catheter (sherwood davis geck) has gotten worse over the last 5-6 years. Rptr has been unable to contact mfr over last 2 years because co has been bought/sold multiple times. When rptr spoke with mfr 2 years ago (sent in product) told they would explore problem. Yet problem is worse/no corrective action. Rptr now unable to locate/contact mfr. Device constantly fails and failure has impacted ability to work, affected social life, because clothing always wet. Device leaks constantly, the now thinner latex ruptures/breaks, pin holes noted as soon as put on catheter, the connection tube not centered. Rptr's last attempt to contact mfr was unsuccessful (no listing).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026200 |
| MDR Report Key | 417253 |
| Date Received | 2002-09-18 |
| Date of Report | 2002-09-18 |
| Date Added to Maude | 2002-09-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHERWOOD DAVIS & GECK |
| Generic Name | TEXAS CATHETER |
| Product Code | EXJ |
| Date Received | 2002-09-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | REF 8884-730300 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 406301 |
| Manufacturer | SHERWOOD DAVIS & GECK |
| Manufacturer Address | * ST LOUIS MO * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-09-18 |