MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-06 for MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX 30055-06 manufactured by Dsm Biomedical.
[37615976]
The device was not returned. Therefore, the investigation is limited to review of the lot history records. The lot history records indicate that the devices in the lot met all pre-determined acceptance criteria. Seroma and infection are known complications that have been reported in the literature to occur in up to 20% of implant-based breast reconstructions. Outcome information has been requested, but was not available as of the date of this report. If additional information is provided, it will be reported in a follow-up report. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[37615977]
A female patient had bilateral, nipple-sparing mastectomy followed by immediate breast reconstruction with bilateral meso biomatrix and tissue expander implantation. At approximately 3 weeks post-operative, she required aspiration of bilateral seroma and began a 5 day course of oral antibiotics. Two days later, mild redness was observed on the lower pole of the left breast. At approximately 4 weeks post-operative, the seroma recurred in the left breast requiring aspiration. Two days later, a 'slight leak' was observed along with continued redness of the left breast. Intravenous antibiotics were started and she was subsequently taken to the operating theater for surgical exploration, washout and vancomycin irrigation of the left breast. She was discharged 3 days later and began a 7 day course of oral antibiotics. During the following two weeks, the left breast seemed to be healing fine. However, redness and swelling of the left breast recurred approximately one month after the surgical exploration. The tissue expander and meso biomatrix were subsequently explanted from the left breast. As of the date of this report, the outcome is pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00001 |
| MDR Report Key | 5414566 |
| Date Received | 2016-02-06 |
| Date of Report | 2016-02-05 |
| Date of Event | 2015-12-22 |
| Date Mfgr Received | 2016-01-08 |
| Device Manufacturer Date | 2015-02-03 |
| Date Added to Maude | 2016-02-06 |
| 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 | 2016-02-06 |
| Model Number | 30055-06 |
| Lot Number | C5184 |
| Device Expiration Date | 2016-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-02-06 |