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 2019-05-10 for FLUENT FLUID MANAGEMENT SYSTEM FLT-112 manufactured by Hologic, Inc..
[145116797]
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. Internal complaint reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145116798]
It was reported that during a tissue removal procedure, using the fluent system, tissue built up in the bottom of the tissue trap canister. Due to this issue the canister top partially came off and tissue and fluid spilled onto the floor. As much tissue as possible was collected and sent to pathology. No injury or misdiagnosis was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2019-00117 |
| MDR Report Key | 8601191 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2019-01-14 |
| Date Added to Maude | 2019-05-10 |
| 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 | 2019-05-10 |
| Model Number | FLT-112 |
| Catalog Number | FLT-112 |
| Lot Number | 19A14RD |
| 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 | 2019-05-10 |