MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT INC. ERAPID NEBULIZER HANDSET; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number 17808030

Device Problem Corroded (1131)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Event Description

Pt stated she received her erapid nebulizer handset.She stated the metal part is rusted and the nebulizer cup is brown.Will proceed with a reshipment; pt will return product.

• Brand Name: ERAPID NEBULIZER HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT INC.
• MDR Report Key: 8811529
• MDR Text Key: 151887794
• Report Number: MW5088273
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 83490017806
• UDI-Public: 8349-0017806
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 17808030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR