MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-08-23 for MESO BIOMATRIX 30055-06 manufactured by Dsm Biomedical.
[52746327]
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 complications can not be determined from the provided information or the manufacturing records.
Patient Sequence No: 1, Text Type: N, H10
[52746328]
It was reported that a (b)(6) woman, with (b)(6), underwent a bilateral prophylactic mastectomy with immediate breast reconstruction. Meso biomatrix was implanted along with tissue expanders for reconstruction. After 4 weeks of implantation, patient developed breast pain, rash, low-grade fever, hematoma and infection on the left breast. The post-operative hematoma was drained, the tissue expander was changed and the patient was treated with antibiotics. The meso biomatrix was integrated with the biological tissues and was not explanted. The complication resolved and the patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00012 |
| MDR Report Key | 5896208 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-08-23 |
| Date of Report | 2016-08-23 |
| Date of Event | 2015-10-09 |
| Date Mfgr Received | 2016-07-25 |
| Device Manufacturer Date | 2015-02-03 |
| Date Added to Maude | 2016-08-23 |
| 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 | 2016-08-23 |
| Model Number | 30055-06 |
| Lot Number | C5184 |
| 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 | 2016-08-23 |