MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-12-30 for KENDALL UNK 6146LL manufactured by Covidien.
[21396438]
Foley inserted post epidural. Hung at foot of bed and leaked on floor. Valve in closed position. Valve opened and closed and still leaking. The mfr of this product is kendall. The catalog # 6146ll, the lot# 916755764.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1569909 |
| MDR Report Key | 1569909 |
| Report Source | 99 |
| Date Received | 2009-12-30 |
| Date of Report | 2009-12-15 |
| Date of Event | 2009-12-09 |
| Date Facility Aware | 2009-12-09 |
| Report Date | 2009-12-15 |
| Date Reported to Mfgr | 2009-12-15 |
| Date Added to Maude | 2010-01-07 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL |
| Generic Name | FOLEY CATHETER DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 2009-12-30 |
| Model Number | UNK |
| Catalog Number | 6146LL |
| Lot Number | 916755764 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-30 |