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.
[89243014]
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 one was a (b)(6) year old female (physician's office id number: (b)(4)) that came to the physician's office for a regular check-up post bilateral mastaplexy (surgery date: (b)(6) 2016). Seri surgical scaffold (lot: p14071901a, expiry: 31-aug-2017, product code: scf15x25agen) was used in the procedure. The patient had two areas of redness. One area was on the lateral aspect of the upper left breast and the other was the medial area of the same breast. Both areas were opened, irrigated and debrided. Both areas had a small piece of mesh showing that was clipped and thrown away. Cultures were done on (b)(6) 2017, but the results were not yet available. The patient's normal medications included: exforge, abilify, and triazolam. The patient was prescribed septra ds for two weeks. The device was not explanted. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013417188-2017-00016 |
| MDR Report Key | 6940026 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-11 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-06-14 |
| 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 | P14071901A |
| Device Expiration Date | 2017-08-31 |
| 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 |