MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for INST-GARD SURGICAL MASK W/FOG-FREE ADHESIVE TAPE, GREEN CONVERTORS AT73835 manufactured by Cardinal Health 200, Llc.
[106401706]
Patient Sequence No: 1, Text Type: N, H10
[106401707]
Surgeon found black sticky residue on several of the masks inside the box. Per the surgeon, he found a mask like this last week and tossed the box but is now concerned because there is more than just minimal discoloration it has quite a bit more "it looks like mold but i'm not sure" and something clear and sticky on it. On one of the masks there are black spots and mucous looking residue and on another the black residue is less but appears to be coming from the inside pocket that encloses the metal bar that is used to pinch over the nose and hold the mask in place. The box nor the masks appear to have been contaminated with moisture or fluid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7457648 |
| MDR Report Key | 7457648 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-04-03 |
| Report Date | 2018-04-12 |
| Date Reported to FDA | 2018-04-12 |
| Date Reported to Mfgr | 2018-04-12 |
| Date Added to Maude | 2018-04-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | INST-GARD SURGICAL MASK W/FOG-FREE ADHESIVE TAPE, GREEN CONVERTORS |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2018-04-25 |
| Model Number | AT73835 |
| Catalog Number | AT73835 |
| Lot Number | 188EH394 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 1 BUTTERFIELD TRAIL BLVD EL PASO TX 79906 US 79906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-25 |