MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-04 for NEONATAL RETRUN ELECTRODE E7512 manufactured by Covidien Lp.
[18310459]
The customer reported that the (b)(6) week old patient received a moderate burn at the return electrode site. The burn was described as blanched skin, 2x1cm on the left buttock. The burn was treated with ointment. The operative procedure was a laparoscopic surgery converted to open colon. In addition, a central line was placed at the right subclavian location. The patient also had a circumcision. The site has indicated the incident grounding pad will not be returned to covidien for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[18433629]
Covidien reference #: (b)(4). Date of initial report: (b)(4) 2014. The incident grounding pad was not returned to covidien for evaluation. If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2014-00173 |
| MDR Report Key | 3693296 |
| Report Source | 06 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-02-06 |
| Date of Event | 2014-01-31 |
| Date Mfgr Received | 2014-02-06 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-03-27 |
| 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 | SHARON MURPHY, SR. DIRECTOR |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEONATAL RETRUN ELECTRODE |
| Generic Name | NEONATAL GROUDING PAD |
| Product Code | ODR |
| Date Received | 2014-03-04 |
| Catalog Number | E7512 |
| Lot Number | 33310044X |
| Device Expiration Date | 2015-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-04 |