MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-20 for ACESSA GUIDANCE HAND PIECE 5300 manufactured by Acessa Health Inc..
[95375867]
Device not available for investigation or testing, therefore root cause analysis of device was not possible. Hazard risk analysis (fa-01-0003-q, i. D. 94) describes a possible hazard with packaging being compromised prior to use resulting in contamination of device and patient fever. This is highly unlikely as standard of care is for users to evaluate packaging prior to use. The ifu states do not use if product or packaging is damaged (pl-01-0033-f). Communications with dr. (b)(6) continue to evaluate the patients health and dr. West has stated that currently patient is doing well.
Patient Sequence No: 1, Text Type: N, H10
[95375868]
Patient re-admitted to hospital 10 days following novasure/acessa procedure with tender uterus and low grade fever. Patient has been on iv antibiotics and recently a pic line was administered. Fever and wbc count now down but patient still experiencing break through fevers in low 100's from time to time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2017-00002 |
| MDR Report Key | 7134061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-20 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-11-01 |
| Date Added to Maude | 2017-12-20 |
| 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 | MR. ISAAC RODRIGUEZ |
| Manufacturer Street | 7004 BEE CAVE RD. BLDG. 3, STE. 200 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal | 78746 |
| Manufacturer Phone | 5127850707 |
| Manufacturer G1 | ACESSA HEALTH INC. |
| Manufacturer Street | 7004 BEE CAVE RD. BLDG. 3, STE. 200 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78746 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACESSA GUIDANCE HAND PIECE |
| Generic Name | ACESSA |
| Product Code | HFG |
| Date Received | 2017-12-20 |
| Model Number | 5300 |
| Catalog Number | 5300 |
| Lot Number | UNKNOWN - NOT PROVIDED |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACESSA HEALTH INC. |
| Manufacturer Address | 7004 BEE CAVE RD. BLDG. 3, STE. 200 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-20 |