MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for RED GRID EKG PAPER 61-400-001 manufactured by Healthwatch Technologies.
[8535]
Ekg tracings that are less then one yr old have faded beyond recognition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000641 |
| MDR Report Key | 11334 |
| Date Received | 1994-02-04 |
| Date of Report | 1994-02-03 |
| Date Added to Maude | 1994-02-07 |
| 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 |
| 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 | RED GRID EKG PAPER |
| Product Code | DSF |
| Date Received | 1994-02-04 |
| Model Number | 61-400-001 |
| Catalog Number | 61-400-001 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 11334 |
| Manufacturer | HEALTHWATCH TECHNOLOGIES |
| Manufacturer Address | BROOMFIELD CO 800209918 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-04 |