MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-16 for VALLEYLAB 10FR/CH-6" E2505-10FR manufactured by Covidien / Valleylab.
[4126960]
Covidien valleylab suction coagulator, ref # (b)(4), lot # s3de016x, exp 04/2018 - defect in protective sheath resulting in burn of the upper lip during use in an adenoidectomy case at (b)(6) on (b)(6) 2013. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033495 |
| MDR Report Key | 3527687 |
| Date Received | 2013-12-16 |
| Date of Report | 2013-12-13 |
| Date of Event | 2013-12-13 |
| Date Added to Maude | 2013-12-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALLEYLAB |
| Generic Name | SUCTION COAGULATOR |
| Product Code | FEH |
| Date Received | 2013-12-16 |
| Model Number | 10FR/CH-6" |
| Catalog Number | E2505-10FR |
| Lot Number | S3DE016X |
| Device Expiration Date | 2018-04-30 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN / VALLEYLAB |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-16 |