FDA Adverse Event
Injury
Summary report: N
CAVIWIPES
MDR report key: 3348184
·
Received September 13, 2013
Report
- Report Number
- 1722021-2013-00019
- Event Type
- Injury
- Date Received
- September 13, 2013
- Report Date
- August 22, 2013
- Manufacturer
- METREX RESEARCH
- Product Code
- LRJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT OCCURRED WHILE THE INFANT WAS CURRENTLY IN THE HOSPITAL. THE STAFF USED "NORMAL" DIAPER RASH OINTMENTS FOR TREATMENT AND THE SYMPTOMS SUBSIDED. NO FURTHER MEDICAL ATTENTION OR PRESCRIPTION MEDICATION WAS NECESSARY. TO DATE, THE INFANT IS DOING FINE AND HAS FULLY RECOVERED. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem · 1
A COMPLAINANT ALLEGED THAT A NEWBORN INFANT HAD EXPERIENCED A REACTION WITH THE SYMPTOM OF A RASH ON HIS POSTERIOR AFTER CAVIWIPES WERE ACCIDENTALLY USED AS BABY WIPES FOR THREE (3) DIAPER CHANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461806 | CAVIWIPES | DISINFECTANT, MEDICAL DEVICES | LRJ | METREX RESEARCH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |