MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-01 for VALLEYLAB POLYHESIVE PATIENT RETURN ELECTRODES manufactured by Covidien.
[3036476]
Multiple valley lab pt return electrodes found to have abnormal brown marks, bubbles and folds. Abnormalities were found by staff prior to use and not placed on pts. Valleylab polyhesive pt return electrodes (pres, (b)(4) - wrinkled pad only - only 1 pad - (b)(4) discolorations, (b)(4) - discolorations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027154 |
| MDR Report Key | 2773569 |
| Date Received | 2012-10-01 |
| Date of Report | 2012-10-01 |
| Date Added to Maude | 2012-10-09 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALLEYLAB POLYHESIVE PATIENT RETURN ELECTRODES |
| Generic Name | GROUNDING PADS |
| Product Code | HEI |
| Date Received | 2012-10-01 |
| Returned To Mfg | 2012-09-27 |
| Lot Number | 231904X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Brand Name | VALLEYLAB POLYHESICE PATIENT RETURN ELECTRODES |
| Generic Name | GROUNDING PADS |
| Product Code | GEI |
| Date Received | 2012-10-01 |
| Lot Number | 228141X |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Brand Name | VALLEYLAB POLYHESIVE PATIENT RETURN ELECTRODES |
| Generic Name | GROUNDING PADS |
| Product Code | GEI |
| Date Received | 2012-10-01 |
| Lot Number | 234589X |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-01 |