MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-03-24 for POLYHESIVE II RETURN ELECTRODE E7507 manufactured by Covidien Lp (valleylab).
[1483423]
The customer reported that an incident occurred with a cardio vascular pt. Two generators were in use with two pads; one pad on each of the pt's buttocks. The pt was in the prone position with the pt's weight on the pads, covered by a bair hugger. The pt was prepped with betadine which possibly was under the pad. The injury was found post procedure and described as a 2nd degree burn with blisters in the exact outline of the pad. The pt was transferred directly to critical care from surgery which may account for the delay in detecting the injury.
Patient Sequence No: 1, Text Type: D, B5
[8660594]
(b) (4). To date, the incident sample has not been received for eval. If the sample is received or if additional info pertinent to the incident is obtained, a f/u report will be submitted. The customer was contacted to obtain additional info, including pt gender, age, weight, and type of treatment. The customer indicated they will not provide additional info about this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00187 |
| MDR Report Key | 1645302 |
| Report Source | 06 |
| Date Received | 2010-03-24 |
| Date of Report | 2010-03-03 |
| Date Mfgr Received | 2010-03-03 |
| Date Added to Maude | 2010-07-14 |
| 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 II RETURN ELECTRODE |
| Generic Name | PATIENT RETURN ELECTRODE |
| Product Code | ODR |
| Date Received | 2010-03-24 |
| Catalog Number | E7507 |
| 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 | 2010-03-24 |