MAUDE Adverse Event Report: ACELL, INC. MICROMATRIX

Model Number	MM0030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Swelling (2091)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the lot identified no substantial deviations from the validated processes and demonstrated the product was manufactured and distributed in compliance with fda, state, local and manufacturer operating procedures.Biocompatibility testing per iso 10993 has demonstrated that this product line does not cause adverse responses in test subjects.Usage of this product for hair loss is off label.Due to the subsequent medical intervention and out of an abundance of caution this mdr has been filed.
Event or Problem Description
On (b)(6) 2017 physician injected mixture of platelet rich plasma and micromatrix powder into the scalp area.On (b)(6) 2017 patient returned to the clinic to voice some concerns, and was referred to a dermatologist.Patient stated she was having a reaction and described the area was very painful, there was soreness, but no redness in area, her hair seemed "electric" and began to fall out.Patient claimed no allergies to pork or other substances.Dermatologist ruled out lichenoid reaction.On (b)(6) 2017 patient returned to the clinic with continued complaints, and had skin test performed by original treating physician.On (b)(6) 2017 original treating physician noted that patient had a mildly positive reaction which was described as "red and raised area" by the patient.Per the patient, her primary care physician prescribed antihistamines, and benadryl for sleep.On (b)(6) 2017 it was noted by original treating physician that the redness was resolved, and, based on past history of duloxetine use duloxetine was restarted.

• Brand Name: MICROMATRIX
• Common Device Name: MICROMATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr; columbia MD 21046
• MDR Report Key: 6748995
• Report Number: 3005920706-2017-00004
• Device Sequence Number: 187586
• Product Code: KGN
• UDI-Device Identifier: 00386190001134
• UDI-Public: (01)00386190001134(17)190331(10)008397
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

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: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: MM0030
• Device Lot Number: 008397
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/27/2017
• 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