MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-12 for SERI SURGICAL SCAFFOLD UNK SCF15X25AGEN manufactured by Sofregen, Inc.
[89284052]
On 14-jun-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 three was a (b)(6) female ((b)(6)) that came to the physician's office on (b)(6) 2016 for a regular check-up post removal and replacement of breast implants ((b)(6) 2016). Seri surgical scaffold (lot: p14073101a, expiry: aug-2017, product code: scf15x25agen) was used in the procedure. The patient noticed drainage under the incision. The physician opened the area and a seroma was noted. A drain was placed and no infection was noted. 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 | 3013417188-2017-00018 |
| MDR Report Key | 6944200 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-29 |
| Date of Event | 2016-08-18 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-10-12 |
| 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 | 2017-10-12 |
| Model Number | UNK |
| Catalog Number | SCF15X25AGEN |
| Lot Number | P14073101A |
| 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 | 2017-10-12 |