MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-11 for SERI SURGICAL SCAFFOLD UNK SCF15X25AGEN manufactured by Sofregen, Inc.
[89252337]
On (b)(6) 2017, a physician's office contacted sofregen to report events associated with seri surgical scaffold. The office had four patients with complications regarding the seri surgical scaffold. Patient number two was a (b)(6) female (physician's office id number: 13893) that came to the physician's office for a regular check-up post bilateral mastaplexy (surgery date: (b)(6) 2017). Seri surgical scaffold (lot: p14080101a, expiry: aug-2017, product code: scf15x25agen) was used in the procedure. The patient had a "fluffy areola". Debridement was done and there was no notation that the seri surgical scaffold was visible. The patient came back to the office with the same issue on (b)(6) 2017. The physician noted some necrotic tissue in the same area as before and offered to again do debridement and the patient declined and when to another office for treatment. The patient's medical history was unknown. The device was not explanted. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013417188-2017-00017 |
| MDR Report Key | 6940059 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-11 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-10-11 |
| 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 AVENUE SUITE 100 |
| Manufacturer City | MEDFORD MA 021554288 |
| Manufacturer Country | US |
| Manufacturer Postal | 021554288 |
| Manufacturer Phone | 6176618873 |
| 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 | 2017-10-11 |
| Model Number | UNK |
| Catalog Number | SCF15X25AGEN |
| Lot Number | P14080101A |
| 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 | 2017-10-11 |