MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-21 for NOVO HEALTH SERVICES 7002X 7002 manufactured by Novo Health Services.
[136736939]
The end user finished a two hour open reduction internal fixation (orif) of a distal femur, as she removed the level ii surgical gown (7002) strikethrough was observed on the left forearm (size 4x6"). The recommended gown level for an orif is a level iv or iii gown. The gown was not provided. Currently the end user has not had any follow up care. (b)(6) hospital currently does not supply level iii surgical gowns in a medium. The client relations manager is working with the customer to provide level iii surgical gowns.
Patient Sequence No: 1, Text Type: N, H10
[136736940]
The end user reported strikethrough on the left forearm of a level 2 gown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306225-2019-00002 |
| MDR Report Key | 8357573 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-18 |
| Date of Event | 2019-02-07 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-02-07 |
| Device Manufacturer Date | 2019-01-28 |
| Date Added to Maude | 2019-02-21 |
| 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 |
| Manufacturer Street | 6024 CENTURY OAKS DRIVE |
| Manufacturer City | CHATTANOOGA TN 37416 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37416 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVO HEALTH SERVICES |
| Generic Name | LEVEL II GOWN |
| Product Code | FYA |
| Date Received | 2019-02-21 |
| Model Number | 7002X |
| Catalog Number | 7002 |
| Lot Number | 41873001 |
| 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 | 6024 CENTURY OAKS DRIVE CHATTANOOGA TN 37416 US 37416 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-21 |