MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-09 for FLUENT FLUID MANAGEMENT SYSTEM FLT-112 manufactured by Hologic, Inc..
[145128867]
Lot and 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. Lot number of the disposable 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. Internal complaint reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145128868]
It was reported that during a tissue removal procedure using the fluent system, it was noted that tissue had bypassed the tissue trap and was clogging the bottom of the tissue trap cylinder. The cylinder was noted to be hissing adn blowing bubbles out of the trap when it "exploded. " the cylinder was removed and the tissue was scraped off the bottom. A new tissue trap was put on and the procedure was completed. No injury or misdiagnosis reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2019-00114 |
| MDR Report Key | 8596547 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-05-09 |
| 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 | KRISTIN FORNIERI |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037318491 |
| 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 | 2019-05-09 |
| Model Number | FLT-112 |
| Catalog Number | FLT-112 |
| Lot Number | UNKNOWN |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |