MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-05-07 for FLOUROSCAN INSIGHT2 manufactured by Hologic, Inc.
[145541379]
If additional information is received regarding the reported injury, a follow up will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145541380]
It was reported by a distributor, who received a phone call directly from the customer, that due to an "unruly flex arm" a member of the staff was injured. The severity of the injury or medical intervention was not reported. A field engineer had previously been dispatched to the site and determined that the flex arm needed to be replaced. The insight system has been replaced. Attempts to obtain additional information regarding the reported injury on (b)(6) 2019 have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2019-00045 |
| MDR Report Key | 8587901 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2019-05-07 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2019-05-07 |
| 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 | FLOUROSCAN |
| Generic Name | FLOUROSCAN INSIGHT MINI C-ARM FLOUROSCOPIC IMAGING SYSTEM |
| Product Code | JAA |
| Date Received | 2019-05-07 |
| Model Number | INSIGHT2 |
| Catalog Number | INSIGHT2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-07 |