MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-17 for NATRELLE INSPIRA FULLPROF 295CC SIZER US MSZ-F295 manufactured by Allergan (costa Rica).
[80289994]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling addresses the reported event as follows: each sizer is supplied sterile in a sealed, double package. Sterility of the sizer is maintained only if the packages, including the package seals, are intact. Do not use the product if the packages or seals have been damaged. Do not use damaged or contaminated re-sterilizable sizers.
Patient Sequence No: 1, Text Type: N, H10
[80289996]
Company representative reported the doctor opened a resterilizable sizer and noticed the device "had particles like grit all over it". The device was washed and used.
Patient Sequence No: 1, Text Type: D, B5
[113582427]
A review of the device history record has been completed. No deviations or non-conformances noted. Lab analysis results: visual analysis of the returned device identified: no unusual conditions and no particles as described in the original report. Visual analysis also identified weight to the spec and a cloudy appearance in the gel after the autoclave disinfection cycle. Additional analysis was performed and no particulates were observed. A microscopic analysis was performed which identified the device to be intact and functional. Based on the device analysis the final assessment is: no issues found related with the manufacturing process and no particles on the device were observed. The device was found to be intact and functional.
Patient Sequence No: 1, Text Type: N, H10
[113582428]
Company representative reported the doctor opened a resterilizable sizer and noticed the device "had particles like grit all over it". The device was washed and used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2017-00209 |
| MDR Report Key | 6717556 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-17 |
| Date of Report | 2017-08-24 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-07-27 |
| Device Manufacturer Date | 2017-03-14 |
| Date Added to Maude | 2017-07-17 |
| 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 FULLPROF 295CC SIZER US |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2017-07-17 |
| Returned To Mfg | 2017-07-27 |
| Catalog Number | MSZ-F295 |
| Lot Number | 3033268 |
| 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. Other | 2017-07-17 |