MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2018-01-25 for MESO BIOMATRIX 30055-08 manufactured by Dsm Biomedical.
[98234971]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[98234972]
The surgeon implanted the mesobiomatrix on (b)(6) 2017. It was the first time he was using the device. He also used the sebbin skin tissue expander and filled it with saline. The mesobiomatrix was not under tension as the expander was not filled to maximum capacity. The surgeon indicated that patient had "red breast" & he was concerned about the amount of fluid coming out of the wound. He was aspirating the fluid on a daily basis. He prescribed antibiotics for the patient but also confirmed that there was no infection. The patient did not improve. Revision surgery was performed on (b)(6) 2017. During surgery, he could not identify the mesobiomatrix - it was completely dissolved. The seroma fluid was drained & the tissue expander was deflated. They did not implant another mesh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2017-00005 |
| MDR Report Key | 7219219 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2016-12-08 |
| Date Added to Maude | 2018-01-25 |
| 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 | MRS. ALICE COUSENS |
| Manufacturer Street | 735 PENNSYLVANIA DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4847132165 |
| 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 | 2018-01-25 |
| Model Number | 30055-08 |
| Lot Number | D9207 |
| Device Expiration Date | 2018-11-30 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-01-25 |