MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-05-04 for 3M PARTICULATE RESPIRATOR AND SURGICAL MASK 1870 UNK manufactured by 3m Health Care.
[1494926]
Customer reported, an employee with a history of recently acquired sensitivities wore the 1870 mask 2 times and developed itching, redness with significant welts and her lips were numb and tingling after wearing the mask for 20 minutes. Reportedly symptoms resolved 1-2 hours after the mask was removed, her lips were tingly the next day and eventually resolved. It was reported there was no treatment, she discontinued use.
Patient Sequence No: 1, Text Type: D, B5
[8536909]
Although, there were no medical intervention needed and no permanent damage caused to the user, we eventually decided to report this event to fda. Method - we evaluated the event by reviewing the history of the product on the market. Results - the user has developed allergic reaction to many products in past two years. Conclusions - this is a rare case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2010-00046 |
| MDR Report Key | 1678672 |
| Report Source | 05,06 |
| Date Received | 2010-05-04 |
| Date of Report | 2010-04-29 |
| Date of Event | 2010-02-11 |
| Date Mfgr Received | 2010-02-15 |
| Date Added to Maude | 2012-02-29 |
| 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 | JIZHONG JIN |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517336655 |
| Manufacturer G1 | 3M U.K., PLC |
| Manufacturer Street | HEIGHINGTON LANE, AYCLIFFE |
| Manufacturer City | CO 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 PARTICULATE RESPIRATOR AND SURGICAL MASK |
| Generic Name | SURGICAL MASK |
| Product Code | MSH |
| Date Received | 2010-05-04 |
| Model Number | 1870 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2010-05-04 |