MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-08 for NEONATAL RETURN ELECTRODE E7512 manufactured by Covidien Lp.
[38292974]
(b)(4). The incident sample was discarded by the site and is not available for evaluation. Additional questions in regard to the incident have been asked. If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[38292975]
The customer reported that (b)(6) male infant received a burn at the return pad site. The incident occurred in (b)(6) 2015. The pad had been placed on the patients left outer thigh. A forcefx generator was set at 20 blend. After the procedure when the pad was removed, a burn/blister was observed at the padsite. It was treated with silvadine cream. The incident return pad was discarded. The site has indicated that the generator checked out fine for them and they have not had any further problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2016-00113 |
| MDR Report Key | 5416289 |
| Date Received | 2016-02-08 |
| Date of Report | 2016-01-15 |
| Date Mfgr Received | 2016-01-15 |
| Device Manufacturer Date | 2014-02-17 |
| Date Added to Maude | 2016-02-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| 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 | 0 |
| Brand Name | NEONATAL RETURN ELECTRODE |
| Generic Name | PATIENT GROUNDING PAD, NEONATAL |
| Product Code | ODR |
| Date Received | 2016-02-08 |
| Model Number | E7512 |
| Catalog Number | E7512 |
| Lot Number | 40350140X |
| Device Expiration Date | 2016-02-28 |
| 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 | 2016-02-08 |