MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-11-21 for MESO BIOMATRIX manufactured by Dsm Biomedical.
[60621608]
Manufacturer has made numerous attempts to obtain additional information without success. There has been no design history review as no product information has been provided to date. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[60621609]
The surgeon reported that, post-mastectomy, a patient returned to the operating room for implant exchange and explantation of the meso biomatrix. He stated that he saw a "jelly-like" substance during the explantation. No other information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00016 |
| MDR Report Key | 6118763 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-11-21 |
| Date of Report | 2016-11-21 |
| Date Mfgr Received | 2016-10-12 |
| Date Added to Maude | 2016-11-21 |
| 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 | 2016-11-21 |
| 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 | 2016-11-21 |