MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-07-10 for NEONATAL RETURN ELECTRODE E7512 manufactured by Covidien Lp.
[15202781]
The customer reported that during an appendectomy procedure, the pt rec'd a 2nd degree burn on the left leg. No other info has become available.
Patient Sequence No: 1, Text Type: D, B5
[15530544]
(b)(4). The return of the incident sample has been requested. To date, it has not been rec'd for eval. Add'l questions in regard to the incident have been asked. If the sample is rec'd, or 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 | 1717344-2013-00499 |
| MDR Report Key | 3236069 |
| Report Source | 01,06 |
| Date Received | 2013-07-10 |
| Date of Report | 2013-06-12 |
| Date Mfgr Received | 2013-06-12 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-10-01 |
| 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 DRIVE |
| 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 RETURN ELECTRODE |
| Generic Name | PATIENT RETURN ELECTRODE |
| Product Code | ODR |
| Date Received | 2013-07-10 |
| Catalog Number | E7512 |
| Lot Number | 238826X |
| Device Expiration Date | 2014-08-31 |
| 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 DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-10 |