MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-20 for POLYHESIVE RETURN ELECTRODE E7506 manufactured by Covidien Lp (valleylab).
[1583286]
The customer reported that the day after a wpw (cardiac) ablation procedure, 3rd degree burns were found on the patient's lower right back. The patient was still in the hospital awaiting possible skin graft.
Patient Sequence No: 1, Text Type: D, B5
[8536224]
(b) (4). (b) (4). The incident patient return electrode was discarded and is not available for evaluation. Valleylab patient return electrodes are designed for use in traditional monopolar surgical procedures. The instructions for use warn against the use of these pads in non-traditional procedures that utilize high current, long duty cycles, or both (i. E. Tissue lesioning, tissue ablation, tissue vaporization, and all procedures in which conductive fluids are introduced into the surgical site). If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00276 |
| MDR Report Key | 1668106 |
| Report Source | 05,06 |
| Date Received | 2010-04-20 |
| Date of Report | 2010-03-31 |
| Date of Event | 2010-03-15 |
| Date Mfgr Received | 2010-03-31 |
| Date Added to Maude | 2010-04-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIM SCHWARZ, MANAGER |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYHESIVE RETURN ELECTRODE |
| Generic Name | PATIENT RETURN ELECTRODE |
| Product Code | ODR |
| Date Received | 2010-04-20 |
| Catalog Number | E7506 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP (VALLEYLAB) |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2010-04-20 |