MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-13 for NATRELLE INSPIRA X-FULL 800CC SIZER (US) MSZ-X800 manufactured by Allergan (costa Rica).
[110954202]
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
[110954203]
Physician reported inspira sizer "ruptured" during surgery. Patient contact with the device occurred. The surgery was successfully completed with a back up device.
Patient Sequence No: 1, Text Type: D, B5
[117903610]
Device analysis results: visual analysis of the returned device identified: weight to the spec, crease fold, opening. A microscopic analysis was performed which identify a striated edge opening, consist with use of a surgical tool. Based on the device analysis the final assessment is: a striated edge opening on posterior side due to surgical damage.
Patient Sequence No: 1, Text Type: N, H10
[117903611]
Physician reported inspira sizer "ruptured" during surgery. Patient contact with the device occurred. The surgery was successfully completed with a back up device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2018-04474 |
| MDR Report Key | 7597876 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-13 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-05-16 |
| Date Mfgr Received | 2018-07-21 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2018-06-13 |
| 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 800CC SIZER (US) |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-06-13 |
| Returned To Mfg | 2018-07-02 |
| Catalog Number | MSZ-X800 |
| Lot Number | 3061507 |
| 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 | 2018-06-13 |