MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-10-12 for NATRELLE INSPIRA FULLPROF 415CC SIZER US MSZ-F415 manufactured by Allergan (costa Rica).
[123536266]
A review of the device history record has been completed. No deviations or non-conformances noted. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling: the natrelle? Silicone sizer is not intended as an implantable device. Prior to surgery, the surgeon should be familiar with all information provided by the manufacturer of the breast implant to be used.
Patient Sequence No: 1, Text Type: N, H10
[123536267]
Patient reported unknown side sizer remains implanted.
Patient Sequence No: 1, Text Type: D, B5
[128205350]
Patient Sequence No: 1, Text Type: N, H10
[128205351]
Patient reported unknown side sizer remains implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2018-07706 |
| MDR Report Key | 7960840 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-10-12 |
| Date of Report | 2018-11-15 |
| Date Mfgr Received | 2018-11-12 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2018-10-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SUZANNE WOJCIK |
| Manufacturer Street | 301 W HOWARD LANE SUITE 100 |
| Manufacturer City | AUSTIN TX 78753 |
| Manufacturer Country | US |
| Manufacturer Postal | 78753 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (COSTA RICA) |
| Manufacturer Street | 900 PARKWAY GLOBAL PARK ZONA FRANCA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATRELLE INSPIRA FULLPROF 415CC SIZER US |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-10-12 |
| Catalog Number | MSZ-F415 |
| Lot Number | 3173112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (COSTA RICA) |
| Manufacturer Address | 900 PARKWAY GLOBAL PARK ZONA FRANCA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-12 |