MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-12-07 for MESO BIOMATRIX 30055-06 manufactured by Dsm Biomedical.
[61649675]
The device history record for meso biomatrix lot #c6437 was reviewed and no discrepancies were noted. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[61649676]
It was reported that a (b)(6) female patient who weighed (b)(6), underwent immediate breast reconstruction following a subcutaneous mastectomy of the left breast. With an axillary lymph node dissection. Jackson pratt drains were placed epipectorally and subpectorally for 3 days post-operatively. Patient received intra-operative antibiotics and post-operative antibiotics for 13 days. At 5 weeks post-operative, redness appeared over the entire breast with concentration over the lower lateral pole and there was development of a hematoma. The surgeon first attempted to treat the redness with intravenous antibiotics. The patient underwent an operative revision of the implantation with removal of the silicone prosthesis, removal of the meso biomatrix and clearance of the pocket with jet lavage. It was reported that the meso biomatrix appeared to be disintegrating. The complication has been resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2016-00017 |
| MDR Report Key | 6152195 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-12-07 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-01-04 |
| Date Mfgr Received | 2016-11-10 |
| Device Manufacturer Date | 2015-05-26 |
| Date Added to Maude | 2016-12-07 |
| 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 | 2016-12-07 |
| Model Number | 30055-06 |
| Lot Number | C6437 |
| Device Expiration Date | 2017-04-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-12-07 |