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 2018-01-05 for NATRELLE INSPIRA XF 255G RE-STER SIZER N-SZRX255 manufactured by Allergan (costa Rica).
[96616894]
A review of the device history record has been completed. No deviations or non-conformances noted. Further information from the reporter regarding product status has been requested. No additional information is available at this time. Device labeling: patients should be advised that the sizer may rupture, releasing silicone gel into the surrounding cavity. Causes of rupture include: damage by surgical instruments, such as nicks, slices, or puncture; other trauma during surgery, such as improper handling or manipulation. Do not insert or attempt to repair a damaged sizer. Product examination prior to use: prior to use, examine the re-sterilizable sizer for any evidence of damage or particulate contamination. Do not use any re-sterilizable sizer that may appear to have leaks, nicks or rupture.
Patient Sequence No: 1, Text Type: N, H10
[96616895]
Healthcare professional reported the device ruptured during the implant surgery. It is unknown if silicone gel came into contact with patient or if a back up device was used to complete surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2018-00019 |
| MDR Report Key | 7168860 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-13 |
| Device Manufacturer Date | 2013-08-21 |
| Date Added to Maude | 2018-01-05 |
| 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 | NATRELLE INSPIRA XF 255G RE-STER SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-01-05 |
| Catalog Number | N-SZRX255 |
| Lot Number | 2493327 |
| Device Expiration Date | 2018-07-21 |
| 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 | 2018-01-05 |