INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-12710
- Event Type
- Injury
- Date Received
- August 4, 2023
- Report Date
- October 3, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191606745
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CONTINUED H.6: F2201. 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. THE EVENT OF "SEROMA-LATE" 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. REASON FOR REOPERATION: SEROMA-LATE AND DEVICE RUPTURE.
DEVICE EVALUATION:VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: UNABLE TO OBSERVE THROUGH THE PHOTOS PROVIDED. MALAISE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. DEPESSION-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. OTHER-MEDICAL-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. VARIED INJURIES-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. SEROMA-LATE:UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. VISIBILITY/PALPABILITY:UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. CYST-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. SKIN RUSH/DERMATITIS-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. PAIN-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. CARDIAC COMPLICATION-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. SENSATION INCREASE/DECREASE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. INFLAMMATION/IRRITATION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE ¿CYSTS¿, ¿FRUCTOSE INTOLERANCE¿, ¿SKIN RASHES¿, ¿ECZEMA¿, ¿ACNE¿, ¿SEVERE PAIN IN THORACIC SPINE¿, ¿HEART PALPITATIONS¿, ¿TINNITUS¿, ¿BRAIN-FOG¿, ¿CHRONIC FATIGUE¿, ¿EXHAUSTION¿, ¿NUMBNESS IN THE HANDS¿, ¿DIFFICULTY CONCENTRATING¿, ¿SLEEP DISORDER¿, AND ¿DEPRESSION¿. THESE EVENTS ARE NOT DEVICE RELATED. ADDITIONALLY, ¿PATIENT HAS BEEN EXPERIENCING INCREASING DEFORMATION OF THE RIGHT BREAST SINCE THE BEGINNING OF THIS YEAR¿, ¿RUPTURE¿, AND ¿SEROMA IN THE CAPSULE". THE DEVICE HAS BEEN EXPLANTED.
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE ¿CYSTS¿, ¿FRUCTOSE INTOLERANCE¿, ¿SKIN RASHES¿, ¿ECZEMA¿, ¿ACNE¿, ¿SEVERE PAIN IN THORACIC SPINE¿, ¿HEART PALPITATIONS¿, ¿TINNITUS¿, ¿BRAIN-FOG¿, ¿CHRONIC FATIGUE¿, ¿EXHAUSTION¿, ¿NUMBNESS IN THE HANDS¿, ¿DIFFICULTY CONCENTRATING¿, ¿SLEEP DISORDER¿, AND ¿DEPRESSION¿. THESE EVENTS ARE NOT DEVICE RELATED. ADDITIONALLY, ¿PATIENT HAS BEEN EXPERIENCING INCREASING DEFORMATION OF THE RIGHT BREAST SINCE THE BEGINNING OF THIS YEAR¿, ¿RUPTURE¿, AND ¿SEROMA IN THE CAPSULE". THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951934 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2565191 | 05060191606745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |