MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-26 for KENDALL KENGUARD 3512 * manufactured by The Kendall Co..
[179057]
Rptr was notified that the bedside drain bags that they were supplying had a malfunctioning anti-reflux valve. Rptr tested this item and agreed with the customer. Rptr notified the mfr's rep, who came here on 6/22/00 and also agreed with the customer. Rep has sent an example back to kendall for evaluation to determine the nature, severity, and scope of the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019194 |
| MDR Report Key | 283831 |
| Date Received | 2000-06-26 |
| Date of Report | 2000-06-26 |
| Date of Event | 2000-06-21 |
| Date Added to Maude | 2000-07-03 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 KENGUARD |
| Generic Name | 2 LITER URINARY BEDSIDE DRAIN BAG |
| Product Code | EYZ |
| Date Received | 2000-06-26 |
| Model Number | 3512 |
| Catalog Number | * |
| Lot Number | 210542 |
| ID Number | * |
| Device Expiration Date | 2005-05-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 274664 |
| Manufacturer | THE KENDALL CO. |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-06-26 |