MAUDE Adverse Event Report: 3M HEALTH CARE 3M TIE-0N SURGICAL MASK

Catalog Number 1818

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burning Sensation (2146); Chest Tightness/Pressure (2463)

Event Date 01/15/2015

Event Type  Injury  

Event Description

A female nurse wore a surgical face mask on (b)(6) 2015.Within 5-10 minutes of donning the mask, the nurse alleged a burning, tingling sensation in her mouth.She alleged tightness in the back of her throat and in her chest.She said that the mask had a 'terrible smell'.She removed the mask and the symptoms resolved within one hour.She went to her primary doctor who conducted tests (chest x-ray, ekg, and labs) which revealed no cause.The doctor prescribed an albuterol inhaler.The female nurse alleged a similar but less intense reaction occurred when wearing another 3m mask (different catalog number).She alleged to have experienced similar reactions with other manufacturer's face masks.She indicated in early february she was seen by a allergist who prescribed an inhaled steroid.In addition, the allergist recommended patch testing.The product was not returned for evaluation and no log number was provided.

Manufacturer Narrative

Without the lot number it is not possible to determine the expiration date or manufacturer.

• Brand Name: 3M TIE-0N SURGICAL MASK
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144 100
• Manufacturer (Section G): SUZHOU AVON TEXTILE CO., LTD.; yuanhe town, xiangcheng region; suzhou jiangsu 2151 33; CH 215133
• Manufacturer Contact: linda johnsen ; 3m center, bldg. 275-5w-06; st. paul, MN 55144-1000 ; 6517374376
• MDR Report Key: 4585156
• MDR Text Key: 5447910
• Report Number: 2110898-2015-00009
• Device Sequence Number: 1
• Product Code: FXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other