MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX 30055-06

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-08-10 for MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX 30055-06 manufactured by Dsm Biomedical.

Event Text Entries

[51771093] Review of the device history records revealed no deviations that would contribute to the reported complications. The product met all pre-determined acceptance criteria. Review of sterilization records indicate the product was processed in accordance with product requirements and met all pre-determined acceptance criteria for sterility. The cause of the complication can not be determined from the provided information or the manufacturing records.
Patient Sequence No: 1, Text Type: N, H10


[51771094] It was reported that a (b)(6) year old woman, with a bmi of (b)(6), underwent a right mastectomy followed by immediate single stage breast reconstruction. Meso biomatrix was implanted along with a breast implant for reconstruction. After 3 weeks of implantation, a seroma progressively appeared. At 6 weeks, the seroma was excessive which led to the re-opening of the scar, skin necrosis and extrusion of the mammary implant. The meso biomatrix and the mammary implant were explanted. The complication resolved. The patient was seen by the surgeon 1 month after the implant removal and she is in good health.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2530154-2016-00011
MDR Report Key5865883
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2016-08-10
Date of Report2016-08-09
Date of Event2016-03-11
Date Mfgr Received2016-07-11
Device Manufacturer Date2015-08-13
Date Added to Maude2016-08-10
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 ContactMR. FORDE HANSELL
Manufacturer Street735 PENNSYLVANIA
Manufacturer CityEXTON PA 19341
Manufacturer CountryUS
Manufacturer Postal19341
Manufacturer Phone4847132152
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMESO BIOMATRIX ACELLULAR PERITONEUM MATRIX
Generic NameMESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY
Product CodeOXH
Date Received2016-08-10
Model Number30055-06
Lot NumberC8960
Device Expiration Date2017-07-31
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDSM BIOMEDICAL
Manufacturer Address735 PENNSLYVANIA DRIVE EXTON PA 19341 US 19341


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2016-08-10

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