MAUDE Adverse Event Report: ACELL, INC. MICROMATRIX

Model Number	MM0200
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	12/06/2019
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 platelet rich plasma (prp) was injected into the scalp for the treatment of hair loss.Acell has reason to suspect that the patient also received an additional cosmetic procedure at the time of the hair restoration procedure because surgeon's comment about the patient needing to come in for suture removal.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 acell's operating procedures and federal, state, and local laws and regulations.Furthermore, 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 12/10/2019 acell received notification from a physician that a patient developed swelling of the eyes after a hair restoration procedure which involved scalp injections with micromatrix reconstituted with platelet rich plasma (prp).The procedure was conducted on (b)(6) 2019.The onset date of the patient's adverse reaction is (b)(6) 2019.As a precautionary measure, physician prescribed a course of steroids (medrol pack).Acell has reason to suspect that the patient also received an additional cosmetic procedure at the time of the hair restoration procedure because surgeon's comment about the patient needing to come in for suture removal.

• Brand Name: MICROMATRIX
• Common Device Name: MICROMATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 9555791
• Report Number: 3005920706-2019-00026
• Device Sequence Number: 19337738
• Product Code: KGN
• UDI-Device Identifier: 00386190001172
• UDI-Public: (01)00386190001172(17)210731(10)018080
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/10/2019

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: 07/31/2021
• Device Model Number: MM0200
• Device Catalogue Number: MM0200
• Device Lot Number: 018080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/06/2020
• 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: 62 YR