FDA Adverse Event
Injury
Summary report: N
PLASMABLADE ADENOID TIP
MDR report key: 3010780
·
Received March 19, 2013
Report
- Report Number
- 1226420-2013-00072
- Event Type
- Injury
- Date Received
- March 19, 2013
- Date of Event
- February 7, 2013
- Report Date
- March 19, 2013
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- DWG
- PMA / PMN Number
- K083415
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL METHOD: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. EVAL CODE RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. PRODUCT EVENT: (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
PEDIATRIC PATIENT HAD A SMALL AMOUNT OF POST-OP NASAL BLEEDING AFTER ADENOIDECTOMY. NO TREATMENT REQUIRED TO CONTROL BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114647 | PLASMABLADE ADENOID TIP | ELECTROSURGICAL DEVICE | DWG | MEDTRONIC ADVANCED ENERGY, LLC | PS300-003 | 56271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00006 YR |