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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN UNK SERI SURGICAL SCAFFOLD
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ALLERGAN UNK SERI SURGICAL SCAFFOLD Back to Search Results
Catalog Number UNK SERI SURGICAL SCAFFOLD
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Necrosis (1971)
Event Date 03/24/2014
Event Type  Injury  
Event Description
Healthcare professional reported post implantation of seri and a concomitant unknown breast device, patient presented with "necrosis and nearly the complete skin envelope mortified." physician suspected the event related to the seri device, "and most probably the patient was hospitalized for more than 24 hours for the necessary revision surgery." seri and concomitant breast device were both explanted and discarded.
 
Manufacturer Narrative
The physician discarded the device when it was explanted and it is no longer available for return.Therefore, allergan will not receive it and no analysis or testing will be done.The event of necrosis is a surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
 
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Brand Name
UNK SERI SURGICAL SCAFFOLD
Manufacturer (Section D)
ALLERGAN
medford MA
Manufacturer Contact
karen herrera
71 s. los carneros rd.
goleta, CA 93117
8059615867
MDR Report Key3783965
MDR Text Key4377361
Report Number3008374097-2014-00027
Device Sequence Number1
Product Code OXF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123128
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 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK SERI SURGICAL SCAFFOLD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/24/2014
Initial Date FDA Received04/15/2014
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
Treatment
IMPLANT WITH CONCOMITANT UNKNOWN BREAST DEVICE
Patient Outcome(s) Required Intervention;
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