MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for MESO BIOMATRIX ACELLULAR PERITONEUM MATRIX manufactured by Dsm Biomedical.
[40933185]
The model number and lot number of the device have been requested, but have not been provided. Therefore, based on the available information, the cause of the complications can not be determined. If additional information is provided by the reporter, it will be submitted in a follow-up report. Device was not explanted.
Patient Sequence No: 1, Text Type: N, H10
[40933186]
The had right, unilateral, nipple-sparing mastectomy followed by immediate, single-stage breast reconstruction with 435cc silicone breast implant placement. Meso biomatrix was implanted in right breast as part of the reconstruction. At 1 week post-operative, ecchymosis was observed on the lower half of the breast up to the nipple. The nipple was noted as being vital. There were no signs of infection. At 2 weeks post-operative, the breast was noted as soft, but the nipple was cold and dark. Below the nipple was a cold and dark area with almost no refill. The patient was referred for hyperbaric oxygen treatment and given oral antibiotics. At 3 weeks post-operative, there were no signs of improvement. The patient was tired and anxious, but had no signs of infection. Betadine gauze was placed and she continued on antibiotics. At 3. 5 weeks post-operative, the wound dehisced, the mesh was visible and 'dirty' fluid drained from the wound. She had no fever. There was redness on the lower half of the breast. So, the implant and necrotic skin were removed. The pocket was cleansed, a drain was placed and the wound was closed in layers. Cultures showed no growth. The complications have resolved and the patient is reportedly healthy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00007 |
| MDR Report Key | 5518408 |
| Date Received | 2016-03-22 |
| Date of Report | 2016-03-22 |
| Date of Event | 2015-08-25 |
| Date Mfgr Received | 2016-02-24 |
| Date Added to Maude | 2016-03-22 |
| 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 | 2016-03-22 |
| 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 | 2016-03-22 |