MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-11-05 for POLYHESIVE RETURN ELECTRODE E7506 manufactured by Covidien Lp.
[3976248]
The customer reported that following an abdominal surgical procedure, a 5mm 2nd degree burn was noted on the patient's dorsal penile region. Furacin (nitrofurazone cream) and amicar (aminocaproic acid) were administered. The burn did not occur at the grounding pad site. The grounding pad had been placed on the patient's arm. The incident grounding pad was discarded by the site.
Patient Sequence No: 1, Text Type: D, B5
[11308953]
(b)(4). The incident sample was discarded by the site and was not available for evaluation. Add'l questions in regard to the incident have been asked. If add'l info pertinent to the incident is obtained, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2013-00909 |
| MDR Report Key | 3540032 |
| Report Source | 01,06 |
| Date Received | 2013-11-05 |
| Date of Report | 2013-10-07 |
| Date of Event | 2013-07-20 |
| Date Mfgr Received | 2013-10-07 |
| Date Added to Maude | 2014-02-04 |
| 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 PMQA |
| 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 | POLYHESIVE RETURN ELECTRODE |
| Generic Name | PATIENT RETURN ELECTRODE |
| Product Code | ODR |
| Date Received | 2013-11-05 |
| Catalog Number | E7506 |
| Lot Number | UNK |
| 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 | 2013-11-05 |