MAUDE Adverse Event Report: UNKNOWN CIPROFLOXACIN INHALER; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2023

Event Type  Injury  

Event Description

Reporter called stating that she received a letter from her pharmacy regarding her cipro nebulizer/inhaler, and that it is a recalled product.The letter instructed her to call the fda as an acknowledgment that she received the letter.Reporter said that she was injured last july by the inhaler and reported it but never received a letter from the fda.Reporter does not have a med watch report number regarding last year's incident.

• Brand Name: CIPROFLOXACIN INHALER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19105254
• MDR Text Key: 340309694
• Report Number: MW5153847
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female