MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-01 for MATRISTEM WOUND SHEET manufactured by Acell, Inc..
[32409626]
Acell conducted a retrospective review of complaint records. During this review, it was recognized that based on surgical intervention referenced in the complaint this complaint should have been reported as a mdr pursuant to 21 cfr part 803. Therefore out of an abundance of caution acell is retrospectively reporting this complaint as a mdr. Acell did not receive product numbers or lot numbers for the device in question. However, since it was reported that the procedure was performed in (b)(6) 2011, all matristem wound sheet batch records for lots manufactured september 2009 through september 2011 were reviewed. All acell devices are terminally sterilized via e-beam to a sterility assurance level of 10-6. All acell devices are packaged in a validated double pouched sterile barrier configuration and instructions stipulate handling conditions to preserve sterility. A review of the manufacturing records for these lots identified no substantial deviation and 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 from the attending physician at any time. This mdr has been filed out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[32409627]
Patient with diabetic foot ulcer on right foot was treated with an acell device. An infection was alleged and subsequently an amputation was performed at the right ankle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2015-00039 |
| MDR Report Key | 5257972 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-01 |
| Date of Report | 2013-11-27 |
| Date of Event | 2011-09-02 |
| Date Mfgr Received | 2013-11-27 |
| Date Added to Maude | 2015-12-01 |
| 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 | MATRISTEM WOUND SHEET |
| Generic Name | DRESSING, WOUND, COLLAGEN |
| Product Code | KGN |
| Date Received | 2015-12-01 |
| Operator | PHYSICIAN |
| 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 21046 US 21046 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2015-12-01 |