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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

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ALLERGAN (COSTA RICA) UNK TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE Back to Search Results
Catalog Number UNK TISSUE EXPANDER
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: "dead space, infection, and exposure.".
 
Event Description
Healthcare professional reported "dead space, infection, and exposure" against unknown side device.Device status is unknown.
 
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Brand Name
UNK TISSUE EXPANDER
Type of Device
EXPANDER, SKIN, INFLATABLE
Manufacturer (Section D)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
Manufacturer (Section G)
ALLERGAN (COSTA RICA)
900 parkway global park
zona franca
Manufacturer Contact
chris sprague
12331-a riata trace parkway
building 3
austin, TX 78727
8479375615
MDR Report Key14755844
MDR Text Key294405589
Report Number9617229-2022-11232
Device Sequence Number1
Product Code LCJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K862203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK TISSUE EXPANDER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2022
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 Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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