MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2015-05-15 for 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 1870 manufactured by 3m Health Care.
[5805469]
A male who was conducting respirator fit testing at his med ctr donned a 3m health care particulate respirator and surgical mask, catalog number 1870 on (b)(6) 2015. Within 3 minutes he alleged his face burned where the 3m surgical mask touched his skin. He alleged his eyes watered and burned, his throat became scratchy, he began to sneeze and had shortness of breath. He went to the emergency room where he was given an epinephrine and intravenous benadryl (diphenhydramine). He went to see an allergist the next day.
Patient Sequence No: 1, Text Type: D, B5
[13334068]
The device is undergoing an eval but has not yet been completed. The eval of this mask has not been completed but device has been returned for eval. Contact areas inner web and headband were subject to human repeat insult patch testing (hpirt) and indicated no contact for sensitization based on test subjects. User indicated they use a portacount system for respirator fit testing. He does not use the method of exposure to saccharin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2015-00020 |
| MDR Report Key | 4792437 |
| Report Source | 00,06 |
| Date Received | 2015-05-15 |
| Date Mfgr Received | 2015-04-15 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-05-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA JOHNSEN |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M U.K., PLC |
| Manufacturer Street | HEIGHINGTON LANE |
| Manufacturer City | AYCLIFFE, DURHAM DL56AF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | DL5 6AF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK |
| Generic Name | RESPIRATOR, SURGICAL (CFR878-4040) |
| Product Code | MSH |
| Date Received | 2015-05-15 |
| Returned To Mfg | 2015-04-27 |
| Model Number | NA |
| Catalog Number | 1870 |
| Lot Number | C140221 |
| ID Number | NA |
| Device Expiration Date | 2019-01-22 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-15 |