SERI SURGICAL SCAFFOLD (US) SCF15X25AGEN

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 2017-03-31 for SERI SURGICAL SCAFFOLD (US) SCF15X25AGEN manufactured by Allergan (medford).

Event Text Entries

[71459774] The reported events are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events. The device will not be returned. Therefore, no analysis or testing can be done. 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


[71459895] Physician reported needing to debride the seri? Surgical scaffold for non-incorporation as the patient began to spit seri? Fibrils. After debriding all visible seri? , the patient still complains of spitting an occasional seri fibril and itching. Seri? Was used as reinforcement to keep the areola from becoming stretched and was concomitantly placed with a breast implant. Side not specified.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020862-2017-00008
MDR Report Key6451084
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-03-31
Date of Report2017-03-31
Date Mfgr Received2017-03-08
Device Manufacturer Date2014-04-30
Date Added to Maude2017-03-31
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 NameSERI SURGICAL SCAFFOLD (US)
Generic NameMESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
Product CodeOXF
Date Received2017-03-31
Catalog NumberSCF15X25AGEN
Lot NumberP14030401A
Device Expiration Date2017-03-31
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 2017-03-31

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