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.
[61695565]
Device history record for meso biomatrix lot # c8960 was reviewed and no discrepancies were noted. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[61695566]
It was reported that a female patient who was (b)(6), underwent immediate bilateral breast reconstruction after bilateral mastectomies. This included a sentinel lymph node dissection on the left side. On the left side, a jackson pratt drain was placed epipectorally for 5 days and another one was placed subpectorally for 8 days. On the right side, a jackson pratt drain was placed epipectorally for 4 days and another one was placed subpectorally for 6 days. The patient received intravenous antibiotics intraoperatively and continued receiving antibiotics for a total of 10 days post-operatively. At 11 weeks post-operative, patient presented with redness submammary with an abscess on one breast, which was initially treated with an incision and drainage, and antibiotics. There were no positive cultures. Six days later, patient underwent revision surgery on both breasts. 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 | 2530154-2016-00019 |
| MDR Report Key | 6152080 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-12-07 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-03-04 |
| Date Mfgr Received | 2016-11-10 |
| Device Manufacturer Date | 2015-08-13 |
| 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 | C8960 |
| Device Expiration Date | 2017-07-31 |
| 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 |