MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-12-21 for MESO BIOMATRIX 30055-06 manufactured by Dsm Biomedical.
[63049478]
A design history file review was performed with no major findings or discrepancies related to the reported failure modes. Device not explanted.
Patient Sequence No: 1, Text Type: N, H10
[63049479]
It was reported that a (b)(6) year old woman with invasive ductal breast carcinoma underwent a right side, two-stage mastectomy with implantation of meso biomatrix and a tissue expander on the (b)(6) 2016. It was noted that there was a seroma by the scar which was leaking non-purulent red fluid. Necrosis was also observed. On the (b)(6) 2016 the necrosis was removed. On the (b)(6) 2016 there was a negative culture but the patient was treated with antibiotics (augmentin) for 3 days. On the (b)(6) 2016 there was a recurrence of a small seroma with no sign of infection. On the (b)(6) 2016 the tissue expander was inflated. On the (b)(6) 2016 there was persistence of inflammation of the right breast plus urticaria. The patient was treated with antibiotics (augmentin) for 7 days. The patient is currently doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00022 |
| MDR Report Key | 6195855 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-04-27 |
| Date Mfgr Received | 2016-11-22 |
| Device Manufacturer Date | 2016-03-22 |
| Date Added to Maude | 2016-12-21 |
| 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 | 2016-12-21 |
| Model Number | 30055-06 |
| Lot Number | D3494 |
| Device Expiration Date | 2018-02-28 |
| 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 | 2016-12-21 |