MAUDE Adverse Event Report: COVIDIEN MEDIUM SLIP ON BRIEF

Model Number 1605

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Rash (2033)

Event Type  Other  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a brief.The customer reports receiving a rash from the briefs.The customer also stated she went to a walk-in clinic and the doctor gave her an antibiotic, but the customer was unable to name the medication.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

Event Description

Two samples were received for further review however nothing was observed that would indicate a cause for skin irritation.Since a manufacturing lot number was not supplied by the customer, it was not possible to review the device history record (dhr) for the particular manufacture day.Due to the nature of this type of product, it is more than likely that any skin irritation is related to skin sensitivity, and it is worth noting that patient sensitivities may have been a contributing factor.Our raw materials are tested for biocompatibility prior to use and there have been no design changes to this product within the past year that would contribute to any increased probability for skin irritation on patients.At this time, a corrective action will not be implemented.Our current controls are semi-hourly operator inspections of the finished product for meeting specifications and qa monitoring twice per shift.This complaint has been communicated to all affected personnel.This complaint will also be used for trending and tracking purposes.

• Brand Name: MEDIUM SLIP ON BRIEF
• Type of Device: BRIEF
• Manufacturer (Section D): COVIDIEN; 525 north emerald rd.; greenwood SC 29646
• Manufacturer (Section G): COVIDIEN; 525 north emerald road; greenwood SC 29646
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 3999023
• MDR Text Key: 4774833
• Report Number: 1033903-2014-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1605
• Device Catalogue Number: 1605
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other