MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-31 for HUCK TOWEL PACK #123684 COMPONENT #2000 manufactured by Novo Health Services.
[99018008]
The reported event occurred while the patient was under anesthesia. The room was broken down and new supplies were set up causing a delay in start of procedure. Novo health services staff was made aware of the reported event and received re-training on inspection process. The root cause of the reported event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[99018009]
User facility reported that a hair was found on a towel in a minor set up pack. The patient was in the operating room under anesthesia. Surgery was delayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306225-2018-00001 |
| MDR Report Key | 7231921 |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-19 |
| Date Mfgr Received | 2017-12-20 |
| Device Manufacturer Date | 2017-12-08 |
| Date Added to Maude | 2018-01-31 |
| 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 | MRS. REBECCA COX |
| Manufacturer Street | 6024 CENTURY OAKS DR. |
| Manufacturer City | CHATTANOOGA TN 37416 |
| Manufacturer Country | US |
| Manufacturer Postal | 37416 |
| Manufacturer Phone | 8043772259 |
| Manufacturer G1 | NOVO HEALTH SERVICES |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUCK TOWEL |
| Generic Name | FIBER, MEDICAL ABSORBENT |
| Product Code | FRL |
| Date Received | 2018-01-31 |
| Model Number | PACK #123684 COMPONENT #2000 |
| Lot Number | 368708001 |
| ID Number | NI |
| 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 DR. CHATTANOOGA TN 37416 US 37416 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-31 |