MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-10-20 for MESO BIOMATRIX 30055-06 manufactured by Dsm Biomedical.
[57973029]
Review of the device history records revealed no deviations that would contribute to the reported complications.
Patient Sequence No: 1, Text Type: N, H10
[57973030]
It was reported that a (b)(6) year old woman who weighed (b)(6) had a tissue expander and meso biomatrix implanted into her left breast. After two weeks of implantation, the patient developed mild left breast tenderness, with no erythema, and no cellulitis. Ten days later a bilateral seroma was noted below the implant. The seroma was aspirated and the patient received antibiotics for 5 days. Two days later, the patient developed a mild "red breast" on the anterior of the left breast. Three days later, a small seroma on the left breast was aspirated. Two days later, there was a left "red breast" with a very slight fluid leak. Exploration, washout, and vancomycin irrigation of the left breast was performed. The patient was seen in the clinic one week later. It was noted that the redness was "settled" and the drains were removed. Three weeks later, further redness and swelling was noted in the left breast. There was no evidence of seroma. Two hundred cc's were taken out of the tissue expander. Three days later, the left breast was aspirated and believed to be infected. The next day, the tissue expander and the acellular dermal matrix on the left breast were explanted. The meso biomatrix was partially integrated to the overlying skin. The meso which was not integrated was excised. The inferior border of the pectoral muscle was sutured back on the chest wall. Ten weeks later, there was insertion of a tissue expander and fat grafting in the left breast. Four months post this surgery, the surgeon noted that the complications appeared to be due to an inflammatory reaction to the meso biomatrix. The patient is currently in good health and has a new tissue expander in situ.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00015 |
| MDR Report Key | 6044648 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-10-20 |
| Date of Report | 2016-10-20 |
| Date of Event | 2015-12-13 |
| Date Mfgr Received | 2016-09-21 |
| Device Manufacturer Date | 2015-05-26 |
| Date Added to Maude | 2016-10-20 |
| 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 | 2016-10-20 |
| Model Number | 30055-06 |
| Lot Number | C6437 |
| Device Expiration Date | 2017-04-30 |
| 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 | 2016-10-20 |