MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-29 for SERI SURGICAL SCAFFOLD UNKNOWN SCF5X15AGEN manufactured by Sofregen, Inc..
[93210427]
On 30-oct-2017, the following information was received: "with patient (b)(6), the order of events of the ae are as follows: surgery date: (b)(6) 2017. A small amount of drainage and change in his right nipple areolar complex. At the 2 o'clock position there is approximately 3 mm area of thinning with possible exposure of the underlying mesh: (b)(6) 2017. A small area of exposure that is 4 mm in diameter of mesh which was extracted: (b)(6) 2017. An area of mesh exposure has nearly fully resolved: (b)(6) 2017. On (b)(6) 2017, the reporter provided more information. On (b)(6) 2017, male the patient had a procedure in the office that required local anesthetic for the removal of an exposed piece of seri surgical scaffold (4 mm in size). On (b)(6) 2017, the area of exposure was the following information was provided regarding the seri surgical scaffold: lot # p15012601a, expiry: feb 2018, product code: scf5x15agen. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013417188-2017-00020 |
| MDR Report Key | 7067203 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-30 |
| Date Added to Maude | 2017-11-29 |
| 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 |
| Manufacturer Phone | 6176518873 |
| 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 | 2017-11-29 |
| Model Number | UNKNOWN |
| Catalog Number | SCF5X15AGEN |
| Lot Number | P15012601A |
| 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 | 2017-11-29 |