MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-29 for UNK manufactured by Unk.
[67704]
Pt was having a norwood procedure to correct th ventricular defect. The esophagus was burned and is now totally destroyed. The pt will require complete replacement of the esophagus when the pt. Becomes 3 or 4 yrs old. Dr informed rptr that five other infants experienced the same problem around this event date time period. Rptr is concerned about a lot problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011784 |
| MDR Report Key | 108678 |
| Date Received | 1997-07-29 |
| Date of Report | 1997-07-29 |
| Date of Event | 1997-04-30 |
| Date Added to Maude | 1997-07-30 |
| 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 | UNK |
| Generic Name | ECHO-CARDIOGRAPH ELECTRODE |
| Product Code | DXK |
| Date Received | 1997-07-29 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 106812 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1997-07-29 |