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 2018-02-02 for STYLE 410 MF RE-STERILIZABLE SIZER MSZMF420 manufactured by Allergan (costa Rica).
[98918906]
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: each sizer is supplied sterile in a sealed, double package. Sterility of the sizer is maintained only if the packages, including the package seals, are intact. Do not use the product if the packages or seals have been damaged. Do not use damaged or contaminated re-sterilizable sizers.
Patient Sequence No: 1, Text Type: N, H10
[98918907]
Healthcare professional reported that a resterilizable breast implant sizer "tore as it was being inserted through a 4 cm incision. " additional details provided as "only the shell outside the patient broke. The free silicone touched the outside of the patient only. The part of the sizer in the patient was intact and promptly removed. " it is unknown if surgery was completed with a backup device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2018-00384 |
| MDR Report Key | 7237294 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-02 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-09 |
| Device Manufacturer Date | 2014-11-24 |
| Date Added to Maude | 2018-02-02 |
| 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 | 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 | STYLE 410 MF RE-STERILIZABLE SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-02-02 |
| Catalog Number | MSZMF420 |
| Lot Number | 2675500 |
| Device Expiration Date | 2019-10-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2018-02-02 |