MAUDE Adverse Event Report: CONVATEC INC SECUREMENTS; ACCESSORIES, CATHETER

Model Number 37449

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Irritation (1941)

Event Type  malfunction  

Manufacturer Narrative

Device 41 of 50.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported ¿the clear, sticky plastic that wraps around the tube comes loose after twenty-four (24) hours.I'd say the tube section mentioned broke or the clear plastic loosened, so the tube moved and pulled my catheter tube approximately fifty times at least in the past six months.¿ she stated there was "no bleeding but extreme irritation of supra pubic tract and is worried of possible infection from catheter pulling since the strap securement device often moves down her leg." no confirmed diagnosis of infection reported.No photographs depicting the reported complaint issue were received.

• Brand Name: SECUREMENTS
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 9708491
• MDR Text Key: 199494830
• Report Number: 1049092-2020-00084
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37449
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1