MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-03-01 for MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX 30055-06 manufactured by Dsm Biomedical.
[39416367]
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. Device discarded at hospital.
Patient Sequence No: 1, Text Type: N, H10
[39416368]
A female patient had bilateral mastectomy followed by immediate single stage, bilateral breast reconstruction with 320cc textured, silicone gel breast implants. Meso biomatrix was implanted in each breast. Approximately 2 months later, the left breast was observed to have 'thin skin. ' she was started on intravenous antibiotics and the thin skin was excised and closed. On the following day, the wound was reportedly healing. However, 4 days later, the left breast wound dehisced and the implant was visible. The right breast also had an infected appearance. The patient decided to have both implants removed. So that same day, the implants and meso biomatrix were removed bilaterally. At the time of explantation, the surgeon noted the meso biomatrix to be thin and barely recognizable. Intravenous antibiotics were continued for 24 hours, followed by oral antibiotics for 5 days. The dehiscence were reported to have resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00002 |
| MDR Report Key | 5470915 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-03-01 |
| Date of Report | 2016-03-01 |
| Date of Event | 2015-12-04 |
| Date Mfgr Received | 2016-02-03 |
| 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 | 3 |
| 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 |