MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-31 for MICROMATRIX MM0030 manufactured by Acell, Inc..
[119056997]
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 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
[119056998]
On (b)(6) 2018 acell received notification from a nurse that a patient developed lumps at the injection sites and experienced itching after conducting a hair restoration procedure with micromatrix and platelet rich plasma (prp). The lumps are described as varying in size, raised and painful to the touch. The procedure was done on (b)(6) 2018 and patient developed adverse reactions starting the same day. Benadryl provided relief of the itching, ibuprofen provided some minor pain relief and dose pack of prednisone was prescribed. Patient was last seen on (b)(6) 2018. The lumps on head have improved and are smaller in size, prednisone provided some relief. Patient has an autoimmune disease scleroderma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2018-00015 |
| MDR Report Key | 7838808 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-03 |
| Date Added to Maude | 2018-08-31 |
| 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 | 2018-08-31 |
| Model Number | MM0030 |
| Catalog Number | MM0030 |
| Lot Number | 010358 |
| Device Expiration Date | 2019-09-30 |
| 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 21045 US 21045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-31 |