MAUDE Adverse Event Report: ACELL, INC. MICROMATRIX

Model Number	MM0020
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033)
Date of Event	04/23/2019
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 0.9% bacteriostatic sodium chloride was injected into the scalp for treatment of alopecia and the subsequent medical intervention required to relieve her symptoms.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 (b)(6) 2019 acell received notification from a nurse that a patient developed a rash, nodules under skin at some injection sites and severe itching after a hair restoration procedure with micromatrix diluted with 0.9% bacteriostatic sodium chloride.The procedure was done on (b)(6) 2019 and the patient reported the adverse reactions started on (b)(6) 2019.Benadryl provided little relief and on (b)(6) 2019 the patient was prescribed prednisone (60mg on day one, 40mg for 5 days).The patient was last seen on (b)(6) 2019, and as of (b)(6) 2019 is doing better as prednisone provided some relief.

• Brand Name: MICROMATRIX
• Common Device Name: MICROMATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 8642769
• Report Number: 3005920706-2019-00007
• Device Sequence Number: 14028036
• Product Code: KGN
• UDI-Device Identifier: 00386190001127
• UDI-Public: (01)00386190001127(17)200531(10)012511
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: 05/31/2020
• Device Model Number: MM0020
• Device Catalogue Number: MM0020
• Device Lot Number: 012511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/24/2019
• 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: Required Intervention
• Patient Age: 46 YR