MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT SRM-310 manufactured by Allergan (costa Rica).
[186731346]
A review of the device history record has been completed. No deviations or non-conformances noted. The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The reason for reoperation is capsular contracture, baker grade iv.
Patient Sequence No: 1, Text Type: N, H10
[186731347]
Healthcare professional reported right side capsular contracture, baker grade iv. Device remains implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2020-05136 |
| MDR Report Key | 9906683 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2018-06-07 |
| 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 SMOOTH SILICONE GEL FILLED BREAST IMPLANT |
| Generic Name | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED |
| Product Code | FTR |
| Date Received | 2020-03-31 |
| Model Number | SRM-310 |
| Catalog Number | SRM-310 |
| Lot Number | 3213015 |
| 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. Required No Informationntervention | 2020-03-31 |