MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-01 for MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX 30055-06 manufactured by Dsm Biomedical.
[39424978]
Review of the device history records does not have deviations that would contribute to the reported complications. The product met all pre-determined acceptance criteria. Review of sterilization records indicate the product was processed in accordance with product requirements and met all pre-determined acceptance criteria for sterility. The cause of the complication can not be determined from the provided information or the manufacturing records.
Patient Sequence No: 1, Text Type: N, H10
[39424979]
The patient presented with capsular contracture of the left breast following a prior breast reconstruction. On (b)(6) 2015, the left breast was revised with capsulectomy, meso biomatrix implantation and implantation of a new breast implant (size and manufacturer not reported). Approximately 6 months later, she presented with a clinically infected left breast. It was described as diffuse redness and pain over the entire breast with some fluid surrounding the implant and a little edema. She had no fever. She was admitted to the hospital and started on intravenous antibiotics. After 2 days of iv antibiotics the infection worsened with dehiscence of the surgical scar. Therefore, the breast implant and meso biomatrix were surgically removed. Prior to removal, meso biomatrix was observed to be integrated at the periphery of the device but not in the center. The infection and dehiscence were reported to have resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00005 |
| MDR Report Key | 5471832 |
| Date Received | 2016-03-01 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-01-18 |
| Date Mfgr Received | 2016-02-12 |
| Device Manufacturer Date | 2014-07-28 |
| Date Added to Maude | 2016-03-01 |
| 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. FORDE HANSELL |
| Manufacturer Street | 735 PENNSYLVANIA DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4847132152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX |
| Generic Name | MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXH |
| Date Received | 2016-03-01 |
| Model Number | 30055-06 |
| Lot Number | C0767 |
| Device Expiration Date | 2015-10-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DSM BIOMEDICAL |
| Manufacturer Address | 735 PENNSYLVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-01 |