MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; HOOD, SPP, WHITE, XL

Catalog Number NONSH700WXL

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

Patient Problem Reaction (2414)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a staff member experienced a reaction after putting on a surgeon's hood.It was reported that after five minutes of use the staff member experienced redness, bumps, and swelling to the face, neck, and forehead.It was reported that the staff member took benadryl and following an unknown period of time, self-administered an epi-pen.It was reported that the staff member carries an epi-pen due to a history of allergies.It was reported that the staff member did not follow up with a hospital or doctor's office after the reported incident.It was reported that after taking the stated medications the reported reaction was resolved.It was reported that the original sample was discarded and is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a staff member experienced a reaction after putting on a surgeon's hood.

Manufacturer Narrative

The original sample was reportedly discarded and was not available to be returned to the manufacturer for evaluation.The sample's lot number was provided to the manufacturer.A sample from the lot number was evaluated.Cytoxicity testing was performed and the reported product issue could not be confirmed.Should additional relevant information becomes available, a supplemental medwatch will be submitted.

• Type of Device: HOOD, SPP, WHITE, XL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093 ; 2249311458
• MDR Report Key: 7235125
• MDR Text Key: 98838098
• Report Number: 1417592-2018-00007
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: NONSH700WXL
• Device Lot Number: 30517110003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 53