MAUDE Adverse Event Report: CARDINAL HEALTH BLUE COMFORT BOUFFANT 24 IN

Model Number 3274

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts to obtain samples from the customer were made and the samples have just been received.Therefore; a follow up report will be filed once the sample evaluation has been completed.

Event Description

The patient has allergy conditions and developed a rash around her hairline where the cap fit.Caps are latex free.

Manufacturer Narrative

The customer's sample was received for evaluation.A review of the returned sample did not indicate any abnormal findings that would result in the allergic reaction.A review of the device history record could not be conducted as no lot number was provided.A review of raw material records for the current production indicated that the material used was approved and in compliance with the required specifications.The material used for the bouffant is polypropylene with calcium carbonate fillers, which passed the biocompatibility tests prescribed by the regulatory agency for the intended use.There were no changes to the material composition including elastic and thread.Therefore, based on these findings we are unable to determine the root cause for the issue reported.No corrective action will be taken at this time.We will continue to monitor for any similar reports.

• Brand Name: BLUE COMFORT BOUFFANT 24 IN
• Type of Device: BLUE COMFORT BOUFFANT
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH SINGAPORE 225 PTE LTD; 10 kallang avenue; #10-10/18 aperia; singapore 33951 0; SN 339510
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 4950675
• MDR Text Key: 23155288
• Report Number: 1423537-2015-00055
• Device Sequence Number: 1
• Product Code: FYF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3274
• Device Catalogue Number: 3274
• Device Lot Number: NO LOT GIVEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR