MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-08 for KENDALL 9270-0485 manufactured by Kendall - Ltp The Ludlow Co Lp.
[19895167]
Fetal monitor paper preprinted number was printed in wrong line spacing. The problem was discovered when rptr printed data on paper and that data overlapped preprinted #. May be a "bad" lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026731 |
| MDR Report Key | 427502 |
| Date Received | 2002-11-08 |
| Date of Report | 2002-11-08 |
| Date Added to Maude | 2002-11-15 |
| 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 |
| Generic Name | FETAL MONIT0R PAPER |
| Product Code | KXN |
| Date Received | 2002-11-08 |
| Model Number | NA |
| Catalog Number | 9270-0485 |
| Lot Number | 72752336782892 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 416512 |
| Manufacturer | KENDALL - LTP THE LUDLOW CO LP |
| Manufacturer Address | TWO LUDLOW PARK DR CHICOPEE MA 01022 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-11-08 |