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 2018-04-03 for STYLE 410 SIZER 20-MM115-245 manufactured by Allergan (costa Rica).
[104182749]
The event of 'capsular contracture (baker grade iii)' is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Additional data: additional information regarding the event, product, or patient details has been requested of the reporter by allergan; no additional information is available at this time. A review of the device history record has been completed. No deviations or non-conformances noted. Device labeling: temporary device: natrelle? Re-sterilizable sizers are temporary devices, and are not intended to be used as a permanent implant. They should only be used for temporary intra-operative placement, to assist the surgeon in permanent implant size selection.
Patient Sequence No: 1, Text Type: N, H10
[104182750]
Physician reported left side capsular contracture, baker grade iii. Patient was implanted with a re-sterilizable sizer.
Patient Sequence No: 1, Text Type: D, B5
[116457372]
Device evaluation: visual analysis of the returned device identified: deformation, weight to the spec, yellow particle, cloudy, and voids were observed after autoclave disinfection process. Based on the device analysis the final assessment is: no issues found related with the manufacturing process. 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. Capsular contracture: patients should be advised that capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time. Capsular contracture occurs more commonly in revision patients than in primary augmentation or reconstruction patients. Capsular contracture is also a risk factor for implant rupture, and it is one of the most common reasons for reoperation.
Patient Sequence No: 1, Text Type: N, H10
[116457373]
Health professional reported left side capsular contracture, baker grade iii. Device has been explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2018-02045 |
| MDR Report Key | 7392490 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-04-03 |
| Date of Report | 2018-05-04 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2002-01-19 |
| Date Added to Maude | 2018-04-03 |
| 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 SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-04-03 |
| Catalog Number | 20-MM115-245 |
| Lot Number | 132100 |
| Device Expiration Date | 2007-01-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-03 |