MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for TECHNOL PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK 62408 manufactured by Kimberly-clark Global Sales, Llc.
[186024575]
I purchased 15k pieces surgical n95 from the (b)(6) 6 weeks ago, as the donation for the drs and nurses defend covid-19 virus, while the shipment arrives to (b)(6), they found all mask are defected, some masks had very serious mold issue and water damages. Some were dried elastic band what made the dr and nurse couldn't wear it. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093955 |
| MDR Report Key | 9897139 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-28 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECHNOL PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK |
| Generic Name | RESPIRATOR, SURGICAL |
| Product Code | MSH |
| Date Received | 2020-03-27 |
| Model Number | 62408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK GLOBAL SALES, LLC |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-03-27 |