FDA Adverse Event
Malfunction
Summary report: N
SAFERSONIC TRANSDUCER COVER
MDR report key: 8004031
·
Received October 25, 2018
Report
- Report Number
- 3003623887-2018-00001
- Event Type
- Malfunction
- Date Received
- October 25, 2018
- Date of Event
- August 28, 2018
- Report Date
- October 25, 2018
- Manufacturer
- PHARMASEPT LTD. MEDICAL PRODUCTS
- Product Code
- ITX
- PMA / PMN Number
- K092858
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO FDA REPORT #MW5079712: SURGEON NOTED THAT THE NEOPROBE DEVICE WAS COMPLETELY EXPOSED FROM THE STERILE BAG (SAFERSONIC STERILE-SONOGRAPHY COVER) AFTER USING IT ON THE PATIENT. PATIENT RECEIVED ADDITIONAL DOSE OF ANTIBIOTICS AND ANTIBIOTIC IRRIGATION WAS USED AFTER THE DISCOVERY OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 844219 | SAFERSONIC TRANSDUCER COVER | TRANSDUCER COVER | ITX | PHARMASEPT LTD. MEDICAL PRODUCTS | 7085570195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |