MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-31 for SERI SURGICAL SCAFFOLD UNKNOWN manufactured by Sofregen, Inc..
[84131867]
On (b)(6) 2017, the following information was received via email: "attached is a photo from dr. (b)(6) which didn't incorporate. The patient had her first surgery(b)(6) 2017 and the breast fell since tissue integration didn't take place. She didn't have any other complication associate with seri. With that being said, second procedure was done (b)(6)using seri to repair the breast that didn't take. " attempts to get additional information have been unsuccessful. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013417188-2017-00014 |
| MDR Report Key | 6834452 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-31 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-07-19 |
| Date Mfgr Received | 2017-08-01 |
| Date Added to Maude | 2017-08-31 |
| 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 City | MA |
| Manufacturer Country | US |
| Manufacturer G1 | SOFREGEN, INC |
| Manufacturer Street | 200 BOSTON AVE SUITE 1100 |
| Manufacturer City | MEDFORD MA 021554288 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 021554288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERI SURGICAL SCAFFOLD |
| Generic Name | SERI SURGICAL SCAFFOLD |
| Product Code | OXF |
| Date Received | 2017-08-31 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFREGEN, INC. |
| Manufacturer Address | MEDFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-31 |