MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-04-06 for MESO BIOMATRIX 30055-06 manufactured by Dsm Biomedical.
[71890899]
A design history review was conducted for lot # d8219. All pre-determined acceptance criteria were met and the product was sterilized appropriately. There were no deviations or non-conformances associated with the reported failure mode. Based on the information currently available, no device failure could be determined. The returned sample has been shipped to an outside lab for histological analysis. Any additional information will be added to the complaint file.
Patient Sequence No: 1, Text Type: N, H10
[71890900]
It was reported that a woman, (b)(6). , underwent implantation of bilateral mammary implants (manufactured by groupe sebbin sas) along with meso biomatrix through her mastectomy scars in (b)(6) 2016. The patient presented approximately 2 months later with bilateral extrusion of the implants, possibly due to the meso biomatrix. Surgeon stated that the patient had an allergic reaction but did not determine the source of the reaction. Patient underwent explantation of the mammary implants and the meso biomatrix in (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2017-00001 |
| MDR Report Key | 6464488 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-04-06 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-03-10 |
| Device Manufacturer Date | 2016-10-25 |
| Date Added to Maude | 2017-04-06 |
| 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 |
| 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 | 2017-04-06 |
| Returned To Mfg | 2017-03-10 |
| Model Number | 30055-06 |
| Lot Number | D8219 |
| Device Expiration Date | 2018-10-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-04-06 |