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 2017-07-14 for NATRELLE INSPIRA MODPROF 295CC SIZER US MSZ-M295 manufactured by Allergan (costa Rica).
[80121603]
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
[80121604]
Company representative reported the doctor opened a resterilizable sizer and noticed the device "had particles like grit all over it" and that the "sizer had a cut in it like a paper cut but it was a piece of plastic or silicone". The device was washed and used.
Patient Sequence No: 1, Text Type: D, B5
[113582186]
A review of the device history record has been initiated. If any new, changed, or corrected information is noted, a supplemental medwatch will be submitted. 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. Additional analysis was performed which identified: bubbles in gel after the autoclave cycle. Based on the device analysis the final assessment is: no issues found related with the manufacturing process, no particles on the device were observed and for this reason it is not possible confirm the reported complaint (foreign material on implant). The device was found to be intact and functional.
Patient Sequence No: 1, Text Type: N, H10
[113582187]
Company representative reported the doctor opened a resterilizable sizer and noticed the device "had particles like grit all over it" and that the? Sizer had a cut in it like a paper cut but it was a piece of plastic or silicone". The device was washed and used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2017-00198 |
| MDR Report Key | 6715879 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-14 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-07-27 |
| Device Manufacturer Date | 2016-11-15 |
| Date Added to Maude | 2017-07-14 |
| 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 MODPROF 295CC SIZER US |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2017-07-14 |
| Returned To Mfg | 2017-07-27 |
| Catalog Number | MSZ-M295 |
| Lot Number | 2985184 |
| 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 | 2017-07-14 |