MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-31 for NATRELLE INSPIRA X-FULL 580CC SIZER (US) MSZ-X580 manufactured by Allergan (costa Rica).
[115530893]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. A review of the device history record has been completed. No deviations or non-conformances noted.
Patient Sequence No: 1, Text Type: N, H10
[115530894]
Healthcare professional reported left side "exposed. " device has been explanted.
Patient Sequence No: 1, Text Type: D, B5
[122091138]
Device labeling: potential adverse events that may occur with silicone gel-filled breast implant surgery include: implant rupture, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy. Additional complications after breast implant surgery the following may occur and/or persist, with varying intensity and/or for a varying length of time: hematoma/seroma, implant extrusion, necrosis, delayed wound healing, and breast tissue atrophy/ chest wall deformity. Calcium deposits can form in the tissue capsule surrounding the implant with symptoms that may include pain and firmness. Lymphadenopathy has also been reported in some women with implants.
Patient Sequence No: 1, Text Type: N, H10
[122091139]
Healthcare professional reported left side "exposed. " device has been explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2018-05683 |
| MDR Report Key | 7734532 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-31 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-06-27 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2017-11-09 |
| Date Added to Maude | 2018-07-31 |
| 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 X-FULL 580CC SIZER (US) |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-07-31 |
| Catalog Number | MSZ-X580 |
| Lot Number | 3136926 |
| 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 | 2018-07-31 |