MAUDE Adverse Event Report: ACELL, INC. MICROMATRIX

Model Number	MM0030
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); Swelling (2091)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the stated allergic reaction experienced by the patient after a mixture of platelet rich plasma reconstituted with acell's micromatrix powder 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) 2018 acell received notification from a nurse that a patient developed lumps at the injection sites and experienced itching after conducting a hair restoration procedure with micromatrix and platelet rich plasma (prp).The lumps are described as varying in size, raised and painful to the touch.The procedure was done on (b)(6) 2018 and patient developed adverse reactions starting the same day.Benadryl provided relief of the itching, ibuprofen provided some minor pain relief and dose pack of prednisone was prescribed.Patient was last seen on (b)(6) 2018.The lumps on head have improved and are smaller in size, prednisone provided some relief.Patient has an autoimmune disease scleroderma.

• Brand Name: MICROMATRIX
• Common Device Name: MICROMATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr; columbia MD 21045
• MDR Report Key: 7838808
• Report Number: 3005920706-2018-00015
• Device Sequence Number: 19126505
• Product Code: KGN
• UDI-Device Identifier: 00386190001134
• UDI-Public: (01)00386190001134(17)190930(10)010358
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K153754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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: 09/30/2019
• Device Model Number: MM0030
• Device Catalogue Number: MM0030
• Device Lot Number: 010358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/31/2018
• 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: 58 YR