MAUDE Adverse Event Report: ATRIUM MEDICAL PNEUMOSTAT; BOTTLE, COLLECTION, VACUUM

Device Problem Air Leak (1008)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the article there is a role for ambulatory devices in the initial management of complex ssp.

Event Description

Received an article titled "partial ambulatory management of severe secondary spontaneous pneumothorax.Respiratory medicine case reports".The purpose of the article was to provide evidence to treat secondary spontaneous pneumothorax (ssp) in end-stage lung disease with ambulatory devices.Per the article adverse events included dyspnea and persistent air leak.

• Brand Name: PNEUMOSTAT
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7535868
• MDR Text Key: 108976374
• Report Number: 3011175548-2018-00509
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K984496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR