MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-12 for KENDALL MONO-FLO 6208 * manufactured by Tyco Healthcare Group.
[16396898]
Pt's caregiver was doing a monthly catheter change and when the equipment was connected the kink prevented appropriate to gravity flow of urine. The caregiver had 2 products in possession with the kink noted in the drainage tubing. Visiting nurse sees the pt weekly. The equipment is defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032072 |
| MDR Report Key | 527614 |
| Date Received | 2004-04-12 |
| Date of Report | 2004-04-30 |
| Date of Event | 2004-04-10 |
| Date Added to Maude | 2004-06-03 |
| 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 | 3 |
| 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 | KENDALL MONO-FLO |
| Generic Name | FOLEY CATHETER DRAINAGE BAGS |
| Product Code | FCN |
| Date Received | 2004-05-12 |
| Model Number | 6208 |
| Catalog Number | * |
| Lot Number | 235051164 |
| ID Number | * |
| Device Expiration Date | 2007-12-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 516782 |
| Manufacturer | TYCO HEALTHCARE GROUP |
| Manufacturer Address | * MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Other | 2004-04-12 |