FDA Adverse Event
Injury
Summary report: N
MCKESSON 37-628 1 1000ML STERILE SALINE BOTTLE 61247922 8399
MDR report key: 18300393
·
Received December 8, 2023
Report
- Report Number
- MW5149034
- Event Type
- Injury
- Date Received
- December 8, 2023
- Date of Event
- November 16, 2021
- Report Date
- November 13, 2023
- Manufacturer
- MCKESSON
- Product Code
- FRO
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I HAD A BREAST AUGMENTATION DONE AND WAS USING MCKESSON STERILE SOLUTION ACTIVELY FOR WOUND CARE AND ENDED UP DEVELOPING AN INFECTION WHICH RESULTED IN LOSS OF TISSUE AND SCARRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1885482 | MCKESSON 37-628 1 1000ML STERILE SALINE BOTTLE 61247922 8399 | DRESSING, WOUND, DRUG | FRO | MCKESSON | 37-6281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Female | Other| R | ANTIDEPRESSANT | BIRTH CONTROL |