MAUDE Adverse Event Report: BOEHRINGER INGELHEIM L - SHAPED INHALER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

Dosen't get in her lungs like the old version of the inhalers.On (b)(6) called boehringer ingelheim medical and technical information at (b)(4) to get the manufacturer and distributor information and was told it was manufactured in (b)(4).On (b)(6) forwarded to fda medical device fax number (b)(4).Where purchased/served: (b)(6).Purchase date: (b)(6) 2014.

Event Description

Add'l info rec'd from reporter 06/24/2014: please change combivent back to l-shaped in inhaler.Inhaler i like is shaped like a l, the new has no "umph", it is straight.I don't like suffocating.Hard to breath still after i use the new style.Have you fixed the problem.Hardly get anything in lungs, only throat.

• Brand Name: L - SHAPED INHALER
• Type of Device: L - SHAPED INHALER
• Manufacturer (Section D): BOEHRINGER INGELHEIM; GM
• MDR Report Key: 3853087
• MDR Text Key: 4686696
• Report Number: MW5036460
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2015
• Other Device ID Number: PRODUCT CODE: 2075276 UPC-0597
• Patient Sequence Number: 1