STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-09693
- Event Type
- Injury
- Date Received
- June 6, 2023
- Report Date
- August 30, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191601344
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMITIES NOTED. 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.
VISUAL ANALYSIS : VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: APPEARS TO BE INTACT ON THE PHOTOS. ¿ ANXIETY-PRODUCT/PROCEDURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ LUMP/NODULE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ VARIED INJURIES-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: ¿ RED PARTICLES OBSERVED ON THE SURFACE OF THE DEVICE. ¿ OBSERVED APPEARS TO BE BIOLOGICAL TISSUE NEXT TO THE DEVICE.
PREVIOUS MEDWATCH SUBMISSION NOTED, RUPTURE. UPON FURTHER QUALITY REVIEW, ALLERGAN HAS DETERMINED, THAT RUPTURE IS REPORTED ON THE CONTRALATERAL SIDE ONLY. LEFT SIDE DEVICE IS NOT RUPTURED.
A PATIENT REPORTED THEY EXPERIENCED THE EVENTS OF ¿I¿M TRYING TO FIND OUT WHAT THE SHELL AND FILLING WERE MADE OUT OF. I¿D REALLY APPRECIATE THIS KNOWLEDGE. I AM IN A LOT OF WORRY AND WOULD APPRECIATE THIS AS IT COULD SAVE ME A LOT OF PAIN¿, ¿CURRENTLY HAS 2 RECALLED IMPLANTS¿, ¿LEAKING¿, ¿LUMPS¿, ¿PERSONALITY AND MENTAL STATE HAS DETERIORATED AND CHANGED.¿ "PARANOID AND ACTING STRANGE AND IS NOT LIKE USUALLY IS". ¿SEVERELY DISTRESSED¿, ¿DEFLATED¿, ¿SCARS AND DISTRESS IF THESE ARE REMOVED¿ AND ¿IS CONCERNED ABOUT THE POSSIBILITY OF POISONING FROM LEAKING SILICONE.¿ THIS RECORD RELATES TO THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
DEVICE HAS BEEN EXPLANTED.
A PATIENT REPORTED THEY EXPERIENCED THE EVENTS OF ¿I¿M TRYING TO FIND OUT WHAT THE SHELL AND FILLING WERE MADE OUT OF. I¿D REALLY APPRECIATE THIS KNOWLEDGE. I AM IN A LOT OF WORRY AND WOULD APPRECIATE THIS AS IT COULD SAVE ME A LOT OF PAIN¿, ¿CURRENTLY HAS 2 RECALLED IMPLANTS¿, ¿LEAKING¿, ¿LUMPS¿, ¿PERSONALITY AND MENTAL STATE HAS DETERIORATED AND CHANGED.¿ "PARANOID AND ACTING STRANGE AND IS NOT LIKE USUALLY IS". ¿SEVERELY DISTRESSED¿, ¿DEFLATED¿, ¿SCARS AND DISTRESS IF THESE ARE REMOVED¿ AND ¿IS CONCERNED ABOUT THE POSSIBILITY OF POISONING FROM LEAKING SILICONE.¿ THIS RECORD RELATES TO THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
PREVIOUS MEDWATCH SUBMISSION NOTED, RUPTURE. UPON FURTHER QUALITY REVIEW, ALLERGAN HAS DETERMINED, THAT RUPTURE IS REPORTED ON THE CONTRALATERAL SIDE ONLY. LEFT SIDE DEVICE IS NOT RUPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1235005 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1331823 | 05060191601344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |