MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-05 for STYLE 410 MF RE-STERILIZABLE SIZER N-SZMF295 manufactured by Allergan (costa Rica).
[129372175]
A review of the device history record has been completed. No deviations or non-conformances noted. The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Device labeling: care should be taken to avoid damaging the natrelle? Silicone sizer with sharp instruments during surgery. Such contact may result in sizer rupture. Each device should be continuously monitored throughout the procedure to ensure the structural integrity of the device is not compromised in any way.
Patient Sequence No: 1, Text Type: N, H10
[129372176]
Health professional reported right side capsular contracture, baker grade not specified. Additionally, health professional reported event of rupture. The device has been explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2018-09164 |
| MDR Report Key | 8134544 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-05 |
| Date of Event | 2016-11-20 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2014-07-28 |
| Date Added to Maude | 2018-12-05 |
| 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 | 2018-12-05 |
| Catalog Number | N-SZMF295 |
| Lot Number | 2637038 |
| 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. Required No Informationntervention | 2018-12-05 |