MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-12-21 for MESO BIOMATRIX 30055-06 manufactured by Dsm Biomedical.
[62957989]
A design history file review was performed with no major findings or discrepancies related to the reported failure modes. Device not explanted.
Patient Sequence No: 1, Text Type: N, H10
[62957990]
It was reported that a (b)(6) woman with invasive ductal carcinoma underwent a unilateral (right side) mastectomy with implantation of meso biomatrix and a breast implant on (b)(6) 2015. On (b)(6) 2015 the patient was noted to have a dehiscence of the wound with necrosis and exposure of the implant. She also developed mondor syndrome (thrombophlebitis of the superficial veins of the breast and anterior chest wall). The patient underwent reoperation with replacement of the prosthesis on the (b)(6) 2015. The meso biomatrix was not removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00020 |
| MDR Report Key | 6193213 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-21 |
| Date of Event | 2015-07-21 |
| Date Mfgr Received | 2016-11-22 |
| Device Manufacturer Date | 2014-12-23 |
| Date Added to Maude | 2016-12-21 |
| 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 |
| 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 |
| Generic Name | MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXH |
| Date Received | 2016-12-21 |
| Model Number | 30055-06 |
| Lot Number | C4859 |
| Device Expiration Date | 2016-12-31 |
| 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 PENNSLYVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-21 |