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.
[1548933]
Customer with a severe latex allergy, reported she developed hives that started under the straps, spread to her ears, and then spread all over her body. Reportedly she did not have shortness of breath, treated with zertac, and the hives were gone this morning although her face is still a little red.
Patient Sequence No: 1, Text Type: D, B5
[8646145]
We evaluated the event by reviewing the compliant history of the product on the market. The allergic reaction to the straps is rare. A 3m is monitoring the trend of complaints. Device performed according to specifications. The user has a history of allergy to certain products. No device failure. This is a rare case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2010-00048 |
| MDR Report Key | 1677080 |
| Report Source | 05,06 |
| Date Received | 2010-05-04 |
| Date of Report | 2010-04-30 |
| Date of Event | 2010-03-18 |
| Date Mfgr Received | 2010-03-18 |
| Date Added to Maude | 2011-01-21 |
| 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 |
| Manufacturer City | AYCLIFFE, 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 |