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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN NE UNK MAMMARY IMPLANT
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ALLERGAN NE UNK MAMMARY IMPLANT Back to Search Results
Catalog Number UNK MAMMARY IMPLANT
Device Problem Biofilm coating in Device (1062)
Patient Problem Foreign Body Reaction (1868)
Event Date 02/03/2015
Event Type  Injury  
Event Description
Healthcare professional reported "8 cases" of "double capsule," and in some cases the doctor "stripped off the capsule and biofilm, bathed the implant in antibiotic solution and re-inserted the device into a fresh pocket if it was intact and in good condition." in other cases, "the pt was requesting removal or size change." side unk.Health professional refused to provide any further info.
 
Manufacturer Narrative
Device labeling addresses: "patients should be advised that implants are not considered lifetime devices, and they will potentially undergo implant removal, with or without replacement, over the course of their lives.".
 
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Brand Name
UNK MAMMARY IMPLANT
Manufacturer (Section D)
ALLERGAN NE
la aurora de heredia
CS 
Manufacturer (Section G)
SANTA BARBARA
900 parkway global park zona franca
la aurora de heredia
CS  
Manufacturer Contact
krista alvarado
301 w. howard ln
ste 100
austin, TX 78753
5128132638
MDR Report Key4567314
MDR Text Key5554922
Report Number2024601-2015-00050
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P990074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK MAMMARY IMPLANT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
NO INFO.
Patient Outcome(s) Required Intervention;
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