FDA Adverse Event
Injury
Summary report: N
NURSE ASSIST, LLC
MDR report key: 20091399
·
Received August 28, 2024
Report
- Report Number
- 3002695476-2024-00048
- Event Type
- Injury
- Date Received
- August 28, 2024
- Date of Event
- March 1, 2024
- Report Date
- August 6, 2024
- Manufacturer
- NURSE ASSIST, LLC
- Product Code
- FRO
- UDI-DI
- 00612479199545
- PMA / PMN Number
- K083042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A FOLLOW-UP EMAIL WAS SENT TO MCKESSON COMPLAINTS DEPARTMENT ON 06-AUG-2024 REQUESTING ADDITIONAL INFORMATION TO AID WITH REPORTING AND WITH THE INVESTIGATION.
Description of Event or Problem · 0
DESCRIPTION OF EMAIL RECEIVED FROM COMPLAINT: (B)(6) UTILIZED MCKESSON'S NORMAL SALINE ISOTONIC IRRIGATION SOLUTION ON A LYMPHEDEMA WOUND IN (B)(6) 2024. (B)(6) WOUND BECAME INFECTED AND SHE WAS ULTIMATELY DIAGNOSED WITH A VIBRIO VULNIFICUS BACTERIAL INFECTION. (B)(6) CLAIMS THAT AS A DIRECT AND PROXIMATE RESULT OF CONTAMINATED PRODUCT SHE WAS PLACED WITH A PERIPHERALLY INSERTED CENTRAL CATHETER FOR MULTIPLE ANTIBIOTIC TREATMENT AND CONTINUES TO RECEIVE FOLLOW UP CARE THEREAFTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191076 | NURSE ASSIST, LLC | 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW TOP | FRO | NURSE ASSIST, LLC | 37-6240 | 23086267 | 00612479199545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |