MAUDE Adverse Event Report: ATRIUM MEDICAL EXPRESS MINI MOBILE DRY SEAL DRAIN; BOTTLE, COLLECTION, VACUUM

Catalog Number 16400

Device Problem Air Leak (1008)

Patient Problems Cellulitis (1768); Pain (1994); Pneumothorax (2012)

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 study successful postoperative outpatient chest tube management can be accomplished in select patients.

Event Description

Received an article titled "post-operative outpatient chest tube management: initial experience with a new portable system".The purpose of the article was to review the experience at a single institution with postoperative, outpatient chest tube management using a new portable chest tube device.Per the article adverse events included pneumothorax, empyema, pain, cellulitis and persistent air leak.

• Brand Name: EXPRESS MINI MOBILE DRY SEAL DRAIN
• 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: 7538525
• MDR Text Key: 109101496
• Report Number: 3011175548-2018-00521
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• PMA/PMN Number: K984496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 16400
• Other Device ID Number: 00650862164008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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