MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-10 for HP * manufactured by Hewlett-packard Co. Medical Products Group.
[165048]
Blister noted at previously used tcm sige after patch was removed on three day old infant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015914 |
| MDR Report Key | 214817 |
| Date Received | 1999-03-10 |
| Date of Report | 1999-03-09 |
| Date of Event | 1999-02-10 |
| Date Added to Maude | 1999-03-22 |
| 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 | RISK MANAGER |
| 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 | HP |
| Generic Name | HP TCP CO2/TCPO2 |
| Product Code | KLK |
| Date Received | 1999-03-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 208386 |
| Manufacturer | HEWLETT-PACKARD CO. MEDICAL PRODUCTS GROUP |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 018101099 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-03-10 |