MAUDE Adverse Event Report: REDAX SPA SMART DRAIN CH 15; FLUTED ROUND DRAIN CH 15

Model Number 24703

Device Problems Crack (1135); Noise, Audible (3273)

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

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) distributor has visited and met the health professionals.They have collected the sample and sent it to redax for investigation.We are going to receive it within this week.The first analysis, being unknown the lot involved, was conducted on the verification of similar cases happened in the past on the family "smart drain": looking at the complaint database, we have recorded only one case of breakage in the drainage during year 2015.In this case, the break was happened during the removal of the drain on the side inside the patient (his is the case we are used to record).No situations, as described by the complainant, have ever been filed.

Event Description

On removal of wound drain heard a cracking sound, patient in visible pain, on complete removal of drain noted crack in drain, tvn has confirmed no shard has been left in patient and kept the drain as evidence.

• Brand Name: SMART DRAIN CH 15
• Type of Device: FLUTED ROUND DRAIN CH 15
• Manufacturer (Section D): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• Manufacturer (Section G): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• Manufacturer Contact: daniela malavasi ; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• MDR Report Key: 7989150
• MDR Text Key: 124675815
• Report Number: 3013058659-2018-00009
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other