MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-03 for MULTIVIEW MVM-HW-LT-01 N/A manufactured by .
[91010433]
Device wasn't made available to evaluate. If additional information becomes available a supplement will be filed.
Patient Sequence No: 1, Text Type: N, H10
[91010434]
On oct. 11, 2017, customer reported that during a biopsy procedure the patient had a rupture of the gel silicone implant. We were unable to obtain additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2017-00128 |
| MDR Report Key | 7000457 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-03 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-10-09 |
| Date Mfgr Received | 2017-10-11 |
| Device Manufacturer Date | 2017-05-17 |
| Date Added to Maude | 2017-11-03 |
| 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 | DEBRA ROSENBERG |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIVIEW |
| Generic Name | MULTIVIEW |
| Product Code | LIZ |
| Date Received | 2017-11-03 |
| Model Number | MVM-HW-LT-01 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-03 |