MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-26 for NOVO HEALTH SERVICES 720X manufactured by Novo Health Services.
[128403981]
On (b)(6) 2018, the user facility reported that a cardio-vascular surgeon finished a case and noticed a strike-through, there was blood around his elbow. The gown was not returned for evaluation. A level iii gown is the recommended choice of barrier protection for the case that was performed. The sales/customer representative and the general manger reviewed the packs the hospital receives and it was discovered that they receive level ii and level iv gowns. Novo health services is working with the facility to add level iii gowns to their inventory. It was discussed with the facility the importance of returning any product that a discrepancy has been noted. There has been no further information provided.
Patient Sequence No: 1, Text Type: N, H10
[128403982]
On (b)(6) 2018, the user reported, by email, to their sales representative that they had a strikethrough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306225-2018-00015 |
| MDR Report Key | 8101435 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-11-14 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Date Added to Maude | 2018-11-26 |
| 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 | MS. 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVO HEALTH SERVICES |
| Generic Name | SURGICAL GOWNS |
| Product Code | FYA |
| Date Received | 2018-11-26 |
| Catalog Number | 720X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO HEALTH SERVICES |
| Manufacturer Address | 7086 INDUSTRIAL ROW DRIVE MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-26 |