MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-04-01 for MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX 30055-05 manufactured by Dsm Biomedical.
[41668722]
Review of the device history records revealed no 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
[41668723]
It was reported that the patient had unilateral, skin-sparing mastectomy followed by immediate reconstruction with a becker 35 adjustable implant and meso biomatrix. A surgical drain was placed in the subcutaneous space. The drain was removed when output was less than 50cc per day. The patient took oral antibiotics until the drain was removed. Approximately 1 month post-operative, the patient presented with seroma and a red patch on the left breast. The patient was started on antibiotics. The seroma was drained and the fluid was described as clear. Cultures showed no growth. Five days later, oozing was initially observed through the surgical wound, which later dehisced resulting in mesh exposure. On the next day, the patient returned to the surgical theater. Clear seroma was again drained, which showed no growth in culture. The meso biomatrix was described as 'jelly-like' in appearance and was not incorporated with the subcutaneous tissue. The mesh and implant were removed. The breast pocket was washed out and a new becker 25 adjustable implant was placed. The wound subsequently healed and the patient was well enough to start chemotherapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00008 |
| MDR Report Key | 5541604 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-04-01 |
| Date of Report | 2016-04-01 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-03-04 |
| Device Manufacturer Date | 2015-02-04 |
| Date Added to Maude | 2016-04-01 |
| 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 | 2016-04-01 |
| Model Number | 30055-05 |
| Lot Number | C5183 |
| 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 PENNSYLVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Required No Informationntervention | 2016-04-01 |