MAUDE Adverse Event Report: HUBEI SAFEWAY PROTECTIVE PRODUCTS BLUE COMFORT BOUFFANT 24 IN; CAP, SURGICAL

Model Number 3274

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

Patient Problem Skin Irritation (2076)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Based on the supplier¿s investigation, the device history record review did not indicate any exception that could lead to the reported incident.There was no change in the material composition.One bouffant was returned for visual inspection, there was no abnormality found.Considering the complaint defect category of irritation, the supplier reviewed the raw material and component inspection record and their existing material used for this code 3274, complies to the specification and no exception was detected that could result in this reported issue.The elastic material used for the cap passed bio-compatibility tests required by the regulatory agency for the intended use.Based on the investigation, the root cause could not be determined.The complaint information was provided to the relevant sectors for their awareness.There is no additional action taken at this time, but the supplier will continue to monitor the trend of this type of incident.

Event Description

The end user-clinician experienced rash from the elastic on bouffant cap on forehead.

• Brand Name: BLUE COMFORT BOUFFANT 24 IN
• Type of Device: CAP, SURGICAL
• Manufacturer (Section D): HUBEI SAFEWAY PROTECTIVE PRODUCTS; no. 118, penchang avenue; xiantao hubei 43300 0; CH 433000
• Manufacturer (Section G): HUBEI SAFEWAY PROTECTIVE PRODUCTS; no. 118, penchang avenue; xiantao hubei 43300 0; CH 433000
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 7981447
• MDR Text Key: 124310973
• Report Number: 1423537-2018-00243
• Device Sequence Number: 1
• Product Code: FYF
• UDI-Device Identifier: 00885380019794
• UDI-Public: 00885380019794
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2018,10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3274
• Device Catalogue Number: 3274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Distributor Facility Aware Date: 09/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2018
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other