MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-30 for MICROMATRIX MM1000 manufactured by Acell, Inc..
[118749652]
This mdr is being submitted due to the reported hematoma that occurred during the initial placement of the acell device. During the surgery micromatrix was focused mainly on the exposed areas: bone, tendon and undermined areas; versajet was also used on the wound. The patient has an external fixture device on his leg and ongoing wound vac therapy. Acell has conducted testing on the clotting capabilities of acell materials, including micromatrix in both in vitro and in vivo models. In both models, the use of micromatrix shortened clotting times compared to the controls, indicating a hemostatic effect. 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.
Patient Sequence No: 1, Text Type: N, H10
[118749653]
On(b)(4) 1820, acell, inc. Became aware a patient experienced hematoma formation after application of acell devices on (b)(6) 2018 for an acute wound. The male patient was in a motorcycle accident about 4 weeks earlier where he incurred a large de-gloving injury with exposed bone and tendon on his left leg. Wound vac had been utilized for several weeks prior to the surgery on (b)(6) 2018. During the surgery micromatrix was focused mainly on the exposed areas: bone, tendon and undermined areas; versajet was also used on the wound. The patient has an external fixture device on his leg and ongoing wound vac therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2018-00013 |
| MDR Report Key | 7832457 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-30 |
| Date of Report | 2018-07-31 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-07-31 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2018-08-30 |
| 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 21045 |
| Manufacturer Country | US |
| Manufacturer Postal | 21045 |
| 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 | 2018-08-30 |
| Model Number | MM1000 |
| Catalog Number | MM1000 |
| Lot Number | 012072 |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2018-08-30 |