FLEX HD, HUMAN ALLOGRAFT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2010-10-25 for FLEX HD, HUMAN ALLOGRAFT manufactured by .

Event Text Entries

[1738556] On (b)(6) 2010, a (b)(6) female patient had what is described as 'bilateral mastectomies with first stage reconstruction with tissue expanders. " she is currently undergoing cancer treatment and is immuno-compromised. On (b)(6) 2010, the patient developed signs of an infection of the right breast and was re-admitted to the hospital. The patient was treated with ciprofloxacin. On (b)(6) 2010, cultures of the right breast were taken and (b)(6). As of (b)(6) 2010, the patient is listed as "improved". Dose, frequency & route used: single use, 64. Therapy dates: (b)(6) 2010. Diagnosis for use: soft tissue repair.
Patient Sequence No: 1, Text Type: D, B5


[8855673] Additional lot #0330906031. Additional exp. Date: 12/04/2012.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3001236616-2010-00022
MDR Report Key1882424
Report Source05,06,08
Date Received2010-10-25
Date of Report2010-06-25
Date of Event2010-05-26
Date Mfgr Received2010-06-11
Date Added to Maude2010-10-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSHARON BOLDS
Manufacturer Street125 MAY ST, STE 300
Manufacturer CityEDISON NJ 08837
Manufacturer CountryUS
Manufacturer Postal08837
Manufacturer Phone7326612337
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEX HD, HUMAN ALLOGRAFT
Generic NameNONE
Product CodeLMO
Date Received2010-10-25
Lot Number00392131
Device Expiration Date2012-07-13
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2010-10-25

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