MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-21 for SERI SURGICAL SCAFFOLD UNKNOWN manufactured by Sofregen, Inc.
[83120638]
On 19-jul-2017, (b)(4) received an email from a cosmetic care coordinator: "one of dr. (b)(6) patients experienced unincorporation bilaterally and eventually underwent several surgeries to remove the product and them ultimately removing her breast implants as well. " on 25-jul-2017, additional information was received from the cosmetic care coordinator. On (b)(6) 2016, a patient (initials: (b)(6), dob: (b)(6) 1984) had the seri surgical scaffold implanted to help with breast implants that were dropping. The seri was being used as a sling to hold the implants in place. On (b)(6) 2016, the seri in the left breast was removed and on (b)(6) 2016, the seri in the right breast was removed. The seri was not keeping the breast implants in place. On (b)(6) 2016, the breast implants were replaced. On (b)(6) 2017, she is having surgery to have strattice implanted. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2017-00012 |
| MDR Report Key | 6806831 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-18 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2017-07-20 |
| Date Added to Maude | 2017-08-21 |
| 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 Street | 200 BOSTON AVE. SUITE 1100 |
| Manufacturer City | MEDFORD MA 021554288 |
| Manufacturer Country | US |
| Manufacturer Postal | 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 | 2017-08-21 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-08-21 |