MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-21 for FIBER MEDICAL ABSORBENT 2104D 2000 manufactured by Novo Health Services.
[100781837]
The reported event occurred with the patient under anesthesia and no known impact to the patient was reported. The fiber medical absorbent towel was not returned to the facility for evaluation. Novo health services quality manager conducted in-service training at the facility on the towel inspection process.
Patient Sequence No: 1, Text Type: N, H10
[100781838]
On (b)(6) 2018, the user reported that during draping, the patient the surgeon notice foreign substance on the sterile towel. The patient was re-draped. The patient was under anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000306225-2018-00004 |
| MDR Report Key | 7286900 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-21 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-01-12 |
| Date Mfgr Received | 2018-01-12 |
| Date Added to Maude | 2018-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | REBECCA COX |
| Manufacturer Street | 1416 DOGWOOD WAY |
| Manufacturer City | MEBANE NC 27302 |
| Manufacturer Country | US |
| Manufacturer Postal | 27302 |
| Manufacturer Phone | 8046446007 |
| Manufacturer G1 | NOVO HEALTH SERVICES |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBER MEDICAL ABSORBENT |
| Generic Name | TOWEL, FIBER MEDICAL ABSORBENT |
| Product Code | FRL |
| Date Received | 2018-02-21 |
| Model Number | 2104D |
| Catalog Number | 2000 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO HEALTH SERVICES |
| Manufacturer Address | 1416 DOGWOOD WAY MEBANE NC 27302 US 27302 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-21 |