MAUDE Adverse Event Report: ACELL, INC. MICROMATRIX

Model Number	MM0100F
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Chest Pain (1776); Fever (1858)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the stated reaction experienced by the patient after a mixture of acell's micromatrix powder reconstituted with plasmalyte and platelet rich plasma (prp) was injected into the scalp for the treatment of hair loss.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with fda, state and local laws and regulations and acell's operating procedures.There has been biocompatibility testing performed per iso10993 on acell's micromatrix product line which has demonstrated micromatrix does not cause adverse responses in test subjects.The use of this product for hair loss treatment is off label and not recommended or promoted by acell, inc.
Event or Problem Description
On 9/25/2019 acell received notification from a physician that a patient developed fever and pleurisy like symptoms (chest and back pain) after a hair restoration procedure with micromatrix, plasmalyte and platelet rich plasma (prp).The procedure was done on (b)(6) 2019 and the patient developed the aforementioned symptoms on the same day.There has not been any treatment advised to the patient or medical intervention post incident.

• Brand Name: MICROMATRIX
• Common Device Name: MICROMATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 9218567
• Report Number: 3005920706-2019-00018
• Device Sequence Number: 2947741
• Product Code: KGN
• UDI-Device Identifier: 00386190001165
• UDI-Public: (01)00386190001165(17)210531(10)017096
• Combination Product (Y/N): N
• PMA/510(K) Number: K172399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: MM0100F
• Device Catalogue Number: MM0100F
• Device Lot Number: 017096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR