MAUDE Adverse Event Report: COVIDIEN SURE CARE; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number 1215

Device Problem Clumping in Device or Device Ingredient (1095)

Patient Problems Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the unit is hurting the customer.Upon further clarification from the patient's daughter, she stated that her mother is wearing the pull ups and they have hard crunchy spots on them located in the crotch area.She further stated that this caused her to get a yeast infection and a urinary tract infection.The patient was hospitalized and was put on iv meds then sent her home on oral kelflex and oral diflucan for the yeast infection.She was in (b)(6) hospital for 7 days.

Manufacturer Narrative

A sample was not received for analysis.Since a manufacturing lot number was supplied by the customer, it was possible to review the device history records (dhr) for the particular manufacturing day.There were no rejects but there was downtime reported which could have been related to the reported condition.The most probable root cause would be the top sheet tearing causing the core materials (super absorbent polymer and fluffed wood pulp) to migrate to the patient.Due to the nature of this type of product, it is more than likely that skin irritation is related to skin sensitivity, and it is worth noting that individual patient sensitivities may have been a contributing factor.All raw materials used in the product are tested for biocompatibility.Based on this isolated issue, our corrective actions are to notify plant management 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 type of report mode occurs.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURE CARE
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): COVIDIEN; 525 n.emerald road; greenwood SC 29646
• Manufacturer (Section G): COVIDIEN; 525 n.emerald road; greenwood SC 29646
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6907070
• MDR Text Key: 87973190
• Report Number: 1033903-2017-05002
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1215
• Device Catalogue Number: 1215
• Device Lot Number: 16077G360858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other