MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-06-03 for MATRISTEM WOUND MATRIX WS0307 manufactured by Acell Inc..
[5902457]
Matristem wound matrix was topically applied to a wound. The patient subsequently experienced alleged cellulitis of the left leg and ankle which reportedly required hospitalization and surgery.
Patient Sequence No: 1, Text Type: D, B5
[13502831]
A comprehensive investigation was conducted on discovery. No substantial deviation was identified and all records purport the product was manufactured and distributed sterile in compliance with fda, state, local, and manufacturer operating procedures. There was no report of device failure at the time of surgery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005920706-2015-00021 |
| MDR Report Key | 4823673 |
| Report Source | 00 |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-04 |
| Date of Event | 2011-02-26 |
| Date Mfgr Received | 2015-05-04 |
| Device Manufacturer Date | 2011-05-17 |
| Date Added to Maude | 2015-06-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BARRY BRAINARD |
| Manufacturer Street | 6640 ELI WHITNEY DR STE 200 |
| Manufacturer City | COLUMBIA MD 210460000 |
| Manufacturer Country | US |
| Manufacturer Postal | 210460000 |
| Manufacturer Phone | 7654648198 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATRISTEM WOUND MATRIX |
| Product Code | KGN |
| Date Received | 2015-06-03 |
| Model Number | WS0307 |
| Lot Number | LS045-04 |
| Device Expiration Date | 2012-05-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACELL INC. |
| Manufacturer Address | COLUMBIA MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-03 |