MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-24 for KYS4511 manufactured by Medline Industries Inc..
[76033184]
It was reported during the setup of an amputation a mask broke and fell onto the back table. The procedure was stopped for approximately 30 minutes while the back table was torn down and re-set. The patient remained stable throughout this incident and no injury occurred. The sample was returned and the complaint confirmed. A root cause could not be determined. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[76033185]
It was reported a shield mask fell into the sterile field during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00035 |
| MDR Report Key | 6587188 |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-24 |
| Date Mfgr Received | 2017-05-12 |
| Date Added to Maude | 2017-05-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | FACEMASK, SHIELD |
| Product Code | LYU |
| Date Received | 2017-05-24 |
| Catalog Number | KYS4511 |
| Lot Number | 17066681 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-24 |