MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-11-13 for 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK N/A 1805 manufactured by 3m Health Care.
[31077186]
Information was not provided after attempting to obtain more information. It was noted that the device will be returned but as of the date of this report submission the device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[31077187]
A female nurse in the hospital intensive care unit alleged a sore throat and difficult breathing within 24 hours of donning a model 1805 v-flex(tm) particulate respirator and surgical mask. The nurse was admitted to the hospital for unspecified medical treatment. The nurse has a history of asthma.
Patient Sequence No: 1, Text Type: D, B5
[35031681]
This information was not available at time of initial report. The samples received were visually reviewed and no visual non-conformities were observed in the respirator samples. The lot records for lot a14300501 were requested from the manufacturing facility. These records were reviewed and all the correct components were used and all testing was completed and within specification for this lot. In addition, the processing aids that could contact the respirators during manufacture were reviewed and had not changed in the 5 months before the affected product was manufactured and the cleaning procedures for the manufacturing equipment had not changed in over a year. There are 3 complaints for the applicable catalog number in the past two years, including this complaint. The three complaints are for three separate events. No other complaints have been received since the product was launch in 2013.
Patient Sequence No: 1, Text Type: N, H10
[35031682]
Additional information. The nurse had unspecified acid reflux issues ongoing at the time in october. She alleged severe burning and soreness in the throat almost immediately after donning the mask. She alleged shortness of breath. The nurse used her asthma inhaler and was admitted to the hospital where she was given unspecified breathing treatments. The nurse alleged the sore throat persisted for several days. As before, the nurse stated that she had acid reflux issues ongoing at the time of the sore throat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2015-00049 |
| MDR Report Key | 5221701 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-11-13 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-12-09 |
| Device Manufacturer Date | 2014-10-31 |
| Date Added to Maude | 2015-11-13 |
| 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 | MS. LINDA JOHNSEN |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M COMPANY |
| Manufacturer Street | 610 NORTH COUNTY RD. 19 |
| Manufacturer City | ABERDEEN SD 57401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57401 |
| 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 MASK |
| Product Code | MSH |
| Date Received | 2015-11-13 |
| Model Number | N/A |
| Catalog Number | 1805 |
| Lot Number | A14300501 |
| Device Expiration Date | 2019-10-31 |
| Operator | NURSE |
| 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 | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-13 |