MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-24 for MICROMATRIX MM0020 manufactured by Acell, Inc..
[146222103]
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.
Patient Sequence No: 1, Text Type: N, H10
[146222104]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2019-00007 |
| MDR Report Key | 8642769 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2018-05-08 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BARRY BRAINARD |
| Manufacturer Street | 6640 ELI WHITNEY DR. |
| Manufacturer City | COLUMBIA MD 21046 |
| Manufacturer Country | US |
| Manufacturer Postal | 21046 |
| Manufacturer Phone | 4109538558 |
| Manufacturer G1 | ACELL, INC. |
| Manufacturer Street | 6640 ELI WHITNEY DR. |
| Manufacturer City | COLUMBIA MD 21046 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21046 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROMATRIX |
| Generic Name | MICROMATRIX |
| Product Code | KGN |
| Date Received | 2019-05-24 |
| Model Number | MM0020 |
| Catalog Number | MM0020 |
| Lot Number | 012511 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACELL, INC. |
| Manufacturer Address | 6640 ELI WHITNEY DR. COLUMBIA MD 21046 US 21046 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-24 |