INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-12709
- Event Type
- Injury
- Date Received
- August 3, 2023
- Report Date
- October 2, 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 H6 (HEALTH EFFECT IMPACT CODE): F2201 BIOPSY 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, RUPTURE.
VISUAL ANALYSIS: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, MALAISE-NDR, DEPRESSION-NDR, OTHER-MEDICAL-NDR, VARIED INJURIES-NDR, SEROMA-LATE, CYST-NDR, SKIN RASH/DERMATITIS-NDR, PAIN-NDR, CARDIAC COMPLICATION-NDR, SENSATION INCREASE/ DECREASE-NDR AND INFLAMMATION/IRITATION WAS REQUESTED ON (B)(6) 2023. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG NUMBER THROUGH THE PHOTOS PROVIDED. 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. DEPRESSION-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. 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.
A HEALTHCARE PROFESSIONAL REPORTED LEFT 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¿, ¿DEPRESSION¿ ARE NOT DEVICE RELATED. PATIENT REPRESENTATIVE ALSO REPORTED LEFT SIDE ¿RUPTURE¿, AND ¿SEROMA IN THE CAPSULE¿ . THE DEVICE HAS BEEN EXPLANTED.
A HEALTHCARE PROFESSIONAL REPORTED LEFT 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¿, ¿DEPRESSION¿ ARE NOT DEVICE RELATED. PATIENT REPRESENTATIVE ALSO REPORTED LEFT SIDE ¿RUPTURE¿, AND ¿SEROMA IN THE CAPSULE¿ . THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285442 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2571376 | 05060191606745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |