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 2016-10-12 for STYLE 410 LX RE-STERILIZABLE SIZER N-SZLX255 manufactured by Allergan (costa Rica).
[57201944]
Medwatch sent to fda on 10/12/2016. Follow-up is being performed for device return. If device is received, lab analysis will be performed and findings ill be reported in a supplemental report. Device labeling addresses the reported events as follows: "gel implants may rupture, and saline of gel/saline implants may deflate at any time and require replacement or revision surgery. As rupture are most often clinically silent, a radiological assessment may be required to aid diagnosis. "
Patient Sequence No: 1, Text Type: N, H10
[57201945]
Physician reported rupture of sizer during implantation on the left side. While the physician was turning the sizer, their index finger broke through the silicone capsule of the sizer. Sizer was removed immediately. "some silicone spilled out into the wound and was immediately debrided. "
Patient Sequence No: 1, Text Type: D, B5
[59989763]
Device analysis: visual analysis of the returned device identified: white particles on shell surface, two openings curve in anterior side and weight measurement in specification. A microscopic analysis was performed which identify striated edge in both openings. Based on the device analysis the final assessment is: two openings on shell, consistent with surgical damage.
Patient Sequence No: 1, Text Type: N, H10
[59989764]
Physician reported rupture of sizer during implantation on the left side. While the physician was turning the sizer, their index finger broke through the silicone capsule of the sizer. Sizer was removed immediately. "some silicone spilled out into the wound and was immediately debrided. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2016-00154 |
| MDR Report Key | 6023745 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-10-12 |
| Date of Report | 2016-10-12 |
| Date of Event | 2016-09-13 |
| Date Mfgr Received | 2016-10-21 |
| Device Manufacturer Date | 2016-05-05 |
| Date Added to Maude | 2016-10-12 |
| 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 LX RE-STERILIZABLE SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2016-10-12 |
| Returned To Mfg | 2016-10-07 |
| Catalog Number | N-SZLX255 |
| Lot Number | 2909011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-10-12 |