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 2020-03-12 for FLUENT FLUID MANAGEMENT SYSTEM FLT-100 manufactured by Hologic, Inc.
[183160168]
Serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed. Serial number of the device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[183160169]
It was reported that after successful completion of the procedure, the patient got up to get dressed. Subsequently, the patient blood pressure was "very low" and the patient became unresponsive. Office staff called 911. The patient was transported to the emergency room for observation. Hologic representative states that due to a poor cervical seal and the switching out of multiple under buttocks drapes, the total fluid deficit is unknown. No additional details available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00054 |
| MDR Report Key | 9825348 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-12 |
| 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 | KELSEA LYVER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2636130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUENT FLUID MANAGEMENT SYSTEM |
| Generic Name | HYSTEROSCOPIC INSUFFLATOR |
| Product Code | HIG |
| Date Received | 2020-03-12 |
| Model Number | FLT-100 |
| Catalog Number | FLT-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2020-03-12 |