MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-08-13 for HI PWR DISPOSBL GRNDING PAD DGPHP manufactured by Covidien Lp (valleylab).
[1379871]
The customer reported that following an rf ablation procedure, a burn was found at the pad site on the pt's back. Only one pad had been used. Pt info and degree of burn were not available.
Patient Sequence No: 1, Text Type: D, B5
[8777634]
Covidien reference#: (b)(6). Date of initial report: (b)(6) 2010. The incident device was discarded by the customer and was not available for eval. The device instructions for use caution to use two (2) pads for each procedure using a single electrode, or four (4) pads for each procedure using cluster electrodes. Additionally, the customer reported that the injury was caused by their mishandling of the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00556 |
| MDR Report Key | 1811186 |
| Report Source | 01,05,06 |
| Date Received | 2010-08-13 |
| Date of Report | 2010-07-14 |
| Date of Event | 2010-07-12 |
| Date Mfgr Received | 2010-07-14 |
| Date Added to Maude | 2010-12-08 |
| 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 | HI PWR DISPOSBL GRNDING PAD |
| Generic Name | RF ABLATION ACCESSORY |
| Product Code | ODR |
| Date Received | 2010-08-13 |
| Catalog Number | DGPHP |
| 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 | 2010-08-13 |