MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-23 for MICROMATRIX manufactured by Acell, Inc..
[109064120]
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 his symptoms. A review of the manufacturing records for the alleged lot was not conducted because this information was not provided by the patient and current treating physician. However, all acell devices are manufactured and distributed sterile in compliance with fda, state, local, 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
[109064121]
On 4/25/2018 acell received notification from physician regarding a patient who developed intense itching and generalized urticaria a week after he had a scalp injection with prp and an acell device. The physician who notified acell of the issue was treating the effects of the urticarial and was is not the physician who administered the scalp injection with prp and an acell device. The patient received reconstituted acell micromatrix and prp injections on or about (b)(6) 2018 for alopecia and about 2 weeks post injections, the scalp, face and neck itching began and became quite intense. The patient's hair restoration physician initially treated the patient with benadryl which offered little relief. Shortly thereafter, the patient went to an urgent care clinic where he was treated with prednisone which "offered good relief".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2018-00005 |
| MDR Report Key | 7538413 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-23 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-05-23 |
| 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 | 2018-05-23 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-05-23 |