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 2010-09-02 for POLYHESIVE II RETURN ELECTRODE E7507 manufactured by Covidien Lp (valleylab).
[1352442]
The customer reported three pts suffered burns at the return electrode site. The degree of burn and pt info was not reported. Please reference reports 1717344-2010-00605 and 1717344-2010-00606 for the other two incidents.
Patient Sequence No: 1, Text Type: D, B5
[8781793]
Covidien reference #: (b)(6). Date of initial report: (b)(6)2010. Return of the incident sample has been requested. To date, the incident sample has not been returned for eval. Additional questions in regard to the incident have also been asked. If the sample is received, or if additional info pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00607 |
| MDR Report Key | 1833936 |
| Report Source | 01,05,06 |
| Date Received | 2010-09-02 |
| Date of Report | 2010-08-09 |
| Date of Event | 2010-07-30 |
| Date Mfgr Received | 2010-08-09 |
| Device Manufacturer Date | 2009-12-01 |
| 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 | POLYHESIVE II RETURN ELECTRODE |
| Generic Name | PATIENT RETURN ELECTRODE |
| Product Code | ODR |
| Date Received | 2010-09-02 |
| Catalog Number | E7507 |
| Lot Number | 175947 |
| Device Expiration Date | 2011-12-31 |
| 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 | 2010-09-02 |