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

Model Number	3274
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The end user-clinician experienced rash from the elastic on bouffant cap on forehead.

• Brand Name: BLUE COMFORT BOUFFANT 24 IN
• Common Device Name: CAP, SURGICAL
• Manufacturer (Section D): HUBEI SAFEWAY PROTECTIVE PRODUCTS; no. 118, penchang avenue; xiantao hubei 43300 0; CH 433000
• MDR Report Key: 7981447
• Report Number: 1423537-2018-00243
• Device Sequence Number: 1433979
• Product Code: FYF
• UDI-Device Identifier: 00885380019794
• UDI-Public: 00885380019794
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2018
• Report Date (Section F): 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other