MAUDE Adverse Event Report: COVIDIEN 90089148 WINGS BARIATRIC ADULT BRIEF

Model Number 67095

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Respiratory Distress (2045); Urticaria (2278); Injury (2348)

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with an adult brief.The customer reports the patient used tranquility and then was switched to the covidien product.The patient wore the product the first time and noticed being sore, and product rubbing her skin.The second time the patient wore the product, within 2 hours, her backside and inside of the thighs were bright red.Whelps and redness developed down her legs, on her arms, wrists and armpits.The patient went to the hospital and the doctor diagnosed it as uticaria and prescribed a prednisone pill and cream.The patient complained of itching everywhere and in pain.While in the hospital the patient had trouble breathing and was prescribed a breathing treatment.The patient has copd and is allergic to penicillin, codeine and latex.

Manufacturer Narrative

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

Manufacturer Narrative

The manufacturing facility has been corrected.

Manufacturer Narrative

Samples were received for evaluation and no issues were observed.Samples were sent for biocompatibility testing.The results show that the device materials meet the biocompatibility requirements for its intended use.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.Based on the complaint trending information, our corrective actions are to notify all affected personnel in order to increase awareness of the issue.Complaint trending will continue to be monitored and corrective actions will be implemented if an increase of this failure mode occurs.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 90089148 WINGS BARIATRIC ADULT BRIEF
• Type of Device: ADULT BRIEF
• Manufacturer (Section D): COVIDIEN; 525 north emerald road; greenwood SC 29646
• Manufacturer (Section G): COVIDIEN; 525 north emerald road; greenwood SC 29646
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4196885
• MDR Text Key: 4964021
• Report Number: 1282497-2014-00050
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 67095
• Device Catalogue Number: 67095
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2015
• 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