MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2018-06-08 for MICROMATRIX manufactured by Acell, Inc..
[110573521]
This mdr is being submitted due to the stated 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 her symptoms. A review of the manufacturing records for the alleged lot was not conducted because this information was not provided by the patient. However, all acell devices are manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulation. There has been biocompatibility testing performed per (b)(4) 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
[110573522]
On (b)(6) 2018 acell received notification from an alleged patient who developed nodules in her throat, swollen lymph nodes, rash on hands and feet, shedding and balding after she had a scalp injection with prp, lidocaine and an acell device. The patient received reconstituted acell micromatrix and prp injections via microneedling while under iv sedation on (b)(6) 2018 for hereditary alopecia. Patient experienced a bloody scalp and a very painful stiff neck shortly after the procedure and four days later broke out with a rash on hands and feet as well as nodules on the back of her neck. Follow-up treatment at the er diagnosed patient condition as erythema multiform urticarial response which was treated with steroids for a week and seemed to alleviate the rash on her hands and feet. However, two weeks later around (b)(6) 2018, patient's hair began coming out "in clumps". Patient visited another physician who diagnosed her with alopecia areata.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2018-00007 |
| MDR Report Key | 7585159 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2018-06-08 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-03-23 |
| Date Mfgr Received | 2018-05-15 |
| Date Added to Maude | 2018-06-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2018-06-08 |
| Device Availability | N |
| Device Age | DA |
| 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. Other; 2. Required No Informationntervention | 2018-06-08 |