MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-14 for KENDALL 6206 * manufactured by The Kendall Company.
[15380035]
Urinary bag leaking. No puncture or misuse, bag was defective with a leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 399525 |
| MDR Report Key | 399525 |
| Date Received | 2002-06-14 |
| Date of Report | 2002-06-14 |
| Date of Event | 2002-06-04 |
| Date Facility Aware | 2002-06-04 |
| Report Date | 2002-06-14 |
| Date Reported to FDA | 2002-06-14 |
| Date Reported to Mfgr | 2002-06-14 |
| Date Added to Maude | 2002-06-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL |
| Generic Name | DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 2002-06-14 |
| Model Number | 6206 |
| Catalog Number | * |
| Lot Number | 521521 |
| ID Number | +H10962061/* |
| Device Expiration Date | 2006-12-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 388576 |
| Manufacturer | THE KENDALL COMPANY |
| Manufacturer Address | * MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-14 |