MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-06-25 for POLYHESIVE RETURN ELECTRODE E7506 manufactured by Covidien Lp (valleylab).
[1608605]
The customer reported that a pt was burned at the pad site during cardiac ablation procedure. Only one pad was used in the procedure. The burn was not noticed at the time the pad was removed, but was noted during the pt's post-op visit two weeks after the procedure. No treatment was provided.
Patient Sequence No: 1, Text Type: D, B5
[8638270]
Covidien references#: (b)(4). Date of initial report: (b)(6) 2010. The customer reported the incident device was discarded and is not available for eval. The product instructions for use warn that non-traditional procedures that utilize high current, long duty cycles. Or both (for example: tissue lesioning, tissue ablation, tissue vaporization, and procedures in which conductive fluids such as saline or lactated ringer's solution are introduced into the surgical site for distention or to conduct rf current) increase the risk of excessive heating under a fully applied return electrode to the point of injuring the pt. Use of more than one pt return electrode may help mitigate the increased risk. This info from the ifu was provided to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00432 |
| MDR Report Key | 1742084 |
| Report Source | 05,06 |
| Date Received | 2010-06-25 |
| Date of Report | 2010-06-11 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2010-06-11 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2010-12-07 |
| 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, MGR |
| 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 | 2010-06-25 |
| Catalog Number | E7506 |
| Lot Number | 183047 |
| Device Expiration Date | 2012-04-30 |
| 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 | 2010-06-25 |