MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-01-30 for NOVO HEALTH SERVICES 514000 7404 manufactured by Novo Health Services.
[134491486]
On (b)(6) 2019, the end user, surgical technician/nurse, was completing their set-up for a total knee replacement procedure, when they noticed a small hole/slit in their right sleeve of a surgical gown (7403). The operating room was broken down and then reset-up for the case, while the patient was under anesthesia. This led to the patient having extending time under anesthesia, potential adverse reaction. The small hole/slit in the gown sleeve was verified by the quality manager (qm). The qm provided training with the inspection staff, informing them on possible outcomes. Procedures and policies were reviewed and no changes are noted at this time. It was reported that there was no adverse impact to the patient as a result of extended time under anesthesia and no further information has been provided.
Patient Sequence No: 1, Text Type: N, H10
[134491487]
On (b)(6) 2019, the end user was setting up the operating room for a total knee replacement procedure. The surgical technician noticed a hole in the right sleeve, after sterile set-up was completed and the patient was under anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306225-2018-00016 |
| MDR Report Key | 8289113 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-16 |
| Date of Event | 2019-01-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-01-30 |
| 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 | ZILLERY FORNTER |
| Manufacturer Street | 7086 INDUSTRIAL ROW DRIVE |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5133986406 |
| Manufacturer G1 | NOVO HEALTH SERVICES |
| Manufacturer Street | 4501 E. ACLINE DRIVE SUITE 1 |
| Manufacturer City | TAMPA FL 33605 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVO HEALTH SERVICES |
| Generic Name | GOWN, SURGICAL, L3 |
| Product Code | FYA |
| Date Received | 2019-01-30 |
| Returned To Mfg | 2019-01-10 |
| Model Number | 514000 |
| Catalog Number | 7404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO HEALTH SERVICES |
| Manufacturer Address | 4501 E. ACLINE DRIVE TAMPA FL 33605 US 33605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-30 |