MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-07 for NATRELLE INSPIRA FP 325G RE-STER SIZER N-SZRF325 manufactured by Allergan (costa Rica).
[79745723]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. It is not possible to fully investigate or confirm the alleged event as the product was discarded and is not available for return to allergan for analysis. Device labeling addresses the reported event as follows: how to open sterile product package: prior to use, keep the sizer covered in the inner package, to prevent contact with airborne and surgical field particulate contaminants. Product examination prior to use: prior to use, examine the re-sterilizable sizer for any evidence of damage or particulate contamination. Do not use any re-sterilizable sizer that may appear to have leaks, nicks or rupture. Do not use damaged or contaminated re-sterilizable sizers. Do not use re-sterilizable sizers that have been damaged or deformed during previous surgical operations.
Patient Sequence No: 1, Text Type: N, H10
[79745724]
Healthcare professional reported "upon immediately opening" a reusable sizer they noticed "a small dark debris on surface of implant. " the "particle" was removed easily and the sizer was "irrigated & used. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2017-00197 |
| MDR Report Key | 6694910 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-07 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-06-14 |
| Device Manufacturer Date | 2016-11-04 |
| Date Added to Maude | 2017-07-07 |
| 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 FP 325G RE-STER SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2017-07-07 |
| Catalog Number | N-SZRF325 |
| Lot Number | 2982039 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-07-07 |