MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-03-28 for 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 1860 manufactured by 3m Health Care.
[103777276]
No lot number was provided- without the lot number, we can not determine the udi, expiration date and manufacturing date. No sample was returned for analysis. The 3m surgical respirator is not made with natural rubber latex. The user facility is investigating to confirm the diagnosis and other potential sources of latex that the patient may have been exposed to. End of report.
Patient Sequence No: 1, Text Type: N, H10
[103777277]
A female employee experienced an anaphylactic reaction and alleged that it could be due to a 3m surgical respirator. No information regarding medical intervention was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00037 |
| MDR Report Key | 7379762 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-19 |
| Date Added to Maude | 2018-03-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA JOHNSEN |
| Manufacturer Street | 2510 CONWAY AVENUE BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M COMPANY VALLEY PLANT |
| Manufacturer Street | 600 EAST MEIGS ST. |
| Manufacturer City | VALLEY NE 68064 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68064 |
| 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 | SURGICAL RESPIRATOR |
| Product Code | MSH |
| Date Received | 2018-03-28 |
| Model Number | NA |
| Catalog Number | 1860 |
| Lot Number | UNK |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-03-28 |