UNK SERI SURGICAL SCAFFOLD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-10-20 for UNK SERI SURGICAL SCAFFOLD manufactured by Allergan (medford).

Event Text Entries

[57980354] Device has not been returned. Therefore, no analysis or testing has been done. The event of "pin point skin breakdown" 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.
Patient Sequence No: 1, Text Type: N, H10


[57980355] Physician reported placement of seri surgical scaffold along with concomitant breast implant "9 months ago". During an augmentation procedure. Physician reported "pin point skin breakdown" occurring "5 weeks ago" that did not heal. Treatment plan includes "local debridement and primary closure".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020862-2016-00046
MDR Report Key6044916
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-10-20
Date of Event2016-08-25
Date Mfgr Received2016-09-28
Date Added to Maude2016-10-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SUZANNE WOJCIK
Manufacturer Street301 W HOWARD LANE SUITE 100
Manufacturer CityAUSTIN TX 78753
Manufacturer CountryUS
Manufacturer Postal78753
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (MEDFORD)
Manufacturer Street200 BOSTON AVENUE
Manufacturer CityMEDFORD MA 02155
Manufacturer CountryUS
Manufacturer Postal Code02155
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK SERI SURGICAL SCAFFOLD
Generic NameMESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
Product CodeOXF
Date Received2016-10-20
Catalog NumberUNK SERI SURGICAL SCAFFOLD
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (MEDFORD)
Manufacturer Address200 BOSTON AVENUE MEDFORD MA 02155 US 02155


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-10-20

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