MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-04 for LEVEL I SURGICAL MASK ANTI-FOG FOAM TIES AT71235, AT752005 manufactured by Cardinal Health 200, Llc.
[122645069]
Surgical mask has a metal piece on both internal sides of the mask that caused facial lacerations of some staff during normal wear for invasive procedures. We are pulling the product from our inventory. A design change to mitigate the risk of injury to clinical staff has been requested. Per hospital, informed product was being removed from clinical departments and inventory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7933444 |
| MDR Report Key | 7933444 |
| Date Received | 2018-10-04 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-09-26 |
| Report Date | 2018-09-26 |
| Date Reported to FDA | 2018-09-26 |
| Date Reported to Mfgr | 2018-10-04 |
| Date Added to Maude | 2018-10-04 |
| 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 | LEVEL I SURGICAL MASK ANTI-FOG FOAM TIES |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2018-10-04 |
| Model Number | AT71235, AT752005 |
| Catalog Number | AT71235, AT752005 |
| Lot Number | 1071235, 1752005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-04 |