MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-07-02 for HI PWR DISPOSBL GRNDING PAD DGPHP manufactured by Covidien Lp (valleylab).
[1607729]
The customer reported that after removing the grounding pad at the end of the procedure, a burn was found on the patient's thigh where the pad had been placed. It was reported that a part of the pad peeled and stuck to drape when the position of the patient was changed during the procedure. The burn was described a first degree and treated with ointment. The patient is recovering well.
Patient Sequence No: 1, Text Type: D, B5
[8642578]
(b)(4). To date, the incident device has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted. The device instructions for use state if the patient is repositioned for the surgical procedure, verify that good pad-to-skin contact and cable connections have been maintained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00452 |
| MDR Report Key | 1749579 |
| Report Source | 01,06 |
| Date Received | 2010-07-02 |
| Date of Report | 2010-06-16 |
| Date of Event | 2010-06-14 |
| Date Mfgr Received | 2010-06-16 |
| 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, MANAGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| 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 | GROUNDING PAD |
| Product Code | ODR |
| Date Received | 2010-07-02 |
| 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 DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-02 |