CIDEX 7 DISINFECTING SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-25 for CIDEX 7 DISINFECTING SOLUTION manufactured by Johnson & Johnson.

Event Text Entries

[17760437] In july we began using this product as a cold sterile solution for our hand instruments and compressed air injector. We used this product because we understood it to be osha approved. Since using cidex, we have had several reactions on our patients who we have used the compressed air injector on. The reactions have been from mild to severe necrosis, infection and cellulitis. We have discontinued the use of this product and want to express our concern that it is potentially hazardousinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1156
• MDR Report Key: 1156
• Date Received: 1992-08-25
• Date of Report: 1992-08-03
• Report Date: 1992-08-03
• Date Reported to FDA: 1992-08-03
• Date Added to Maude: 1992-08-31
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CIDEX 7 DISINFECTING SOLUTION
• Generic Name: SAME
• Product Code: LFE
• Date Received: 1992-08-25
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1104
• Manufacturer: JOHNSON & JOHNSON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-08-25