MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-06 for MICROMATRIX MM0200 manufactured by Acell, Inc..
[175013943]
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.
Patient Sequence No: 1, Text Type: N, H10
[175013944]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2019-00026 |
| MDR Report Key | 9555791 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-06 |
| Date of Report | 2019-12-10 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2019-12-10 |
| Device Manufacturer Date | 2019-08-06 |
| Date Added to Maude | 2020-01-06 |
| 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 | 2020-01-06 |
| Model Number | MM0200 |
| Catalog Number | MM0200 |
| Lot Number | 018080 |
| 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. Other | 2020-01-06 |