MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-30 for VALLEY LAB E7506 * manufactured by Valley Lab.
[20931023]
Pt was in surgery for a c-section. After the procedure the grounding pad was removed from pt's right leg and a burn measuring 1. 5cm x 0. 5cm was found below where the ground pad was located. Md made aware and orders rec'd including consult with a general surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 524638 |
| MDR Report Key | 524638 |
| Date Received | 2004-04-30 |
| Date of Report | 2004-04-01 |
| Date of Event | 2004-04-01 |
| Date Added to Maude | 2004-05-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALLEY LAB |
| Generic Name | POLYHESIVE GROUND PAD |
| Product Code | HQP |
| Date Received | 2004-04-30 |
| Model Number | E7506 |
| Catalog Number | * |
| Lot Number | 76333 |
| ID Number | * |
| Device Expiration Date | 2005-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 513766 |
| Manufacturer | VALLEY LAB |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 80301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2004-04-30 |