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 2020-01-28 for FLUENT FLUID MANAGEMENT SYSTEM FLT-112S manufactured by Hologic, Inc.
[178638321]
The date of the event was not provided, the incident date remains unknown. Hologic became aware of this event on january 09 2020. 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. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed. Lot number of the disposable device was 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
[178638322]
It was reported that during a procedure at an unknown date, the tissue trap burst resulting in a lost tissue sample. The device involved was a fluent fluid management system. There is no known impact to patient, no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00011 |
| MDR Report Key | 9640053 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-28 |
| 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 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082636130 |
| 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 | 2020-01-28 |
| Model Number | FLT-112S |
| Catalog Number | FLT-112S |
| 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 | 2020-01-28 |