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 2020-03-31 for INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT N-TRF450 manufactured by Allergan (costa Rica).
[186199456]
Allergan did not submit this mdr within 30 days of becoming aware. Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume. Allergan is implementing a plan to address the increased volumes. 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. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Reason for reoperation: rupture. Device evaluation: visual analysis of the returned device identified: underweight, black particles in the gel/ surface of the shell and broken shell. A microscopic analysis was performed which identify a sharp edge opening assessed as unidentified tear opening. A dimension measurement in the shell was performed which identify the thickness within specification. Based on the device analysis the final assessment is: a sharp opening posterior side assessed as an unidentified (tear) opening.
Patient Sequence No: 1, Text Type: N, H10
[186199457]
Healthcare professional reported a left side rupture. The device has been explanted and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2020-02489 |
| MDR Report Key | 9908285 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2019-12-24 |
| Device Manufacturer Date | 2013-09-11 |
| Date Added to Maude | 2020-03-31 |
| 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 | MRS. MICHELLE BURGESS |
| Manufacturer Street | 12331-A RIATA TRACE PARKWAY BUILDING 3 |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| 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 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT |
| Generic Name | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED |
| Product Code | FTR |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-04 |
| Catalog Number | N-TRF450 |
| Lot Number | 2501911 |
| Device Expiration Date | 2018-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-31 |