MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT N-TRF325 manufactured by Allergan (costa Rica).
[186307664]
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 completed. No deviations or non-conformances noted. Device evaluation: visual analysis of the returned device identified: underweight, broken shell, crease flat and missing piece of the shell. A microscopic analysis was performed which identify sharp edge broken assessed as unidentified tear broken. 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 broken on posterior side due to an unidentified (tear) opening; missing piece of the shell due to inconclusive. 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.
Patient Sequence No: 1, Text Type: N, H10
[186307665]
Physician has reported "implant rupture". Device has been explanted. This relates to the right side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2020-02606 |
| MDR Report Key | 9908232 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-08-26 |
| Date Mfgr Received | 2019-12-02 |
| Device Manufacturer Date | 2011-03-21 |
| 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 | 2020-01-06 |
| Catalog Number | N-TRF325 |
| Lot Number | 2093191 |
| Device Expiration Date | 2016-03-21 |
| 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 |