MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-16 for STYLE 410 MF RE-STERILIZABLE SIZER N-SZMF375 manufactured by Allergan (costa Rica).
[145298197]
A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. Reason for reoperation: rupture. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. These are a known potential adverse events addressed in the product labeling.
Patient Sequence No: 1, Text Type: N, H10
[145298198]
Medical staff reported a rupture of the right device. The device was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2019-03848 |
| MDR Report Key | 8617552 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-04-19 |
| Device Manufacturer Date | 2012-03-15 |
| Date Added to Maude | 2019-05-16 |
| 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 | MRS. MICHELLE BURGESS |
| 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 | 2019-05-16 |
| Catalog Number | N-SZMF375 |
| Lot Number | 2247519 |
| Device Expiration Date | 2017-02-15 |
| 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; 2. Required No Informationntervention | 2019-05-16 |