MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-02 for SERI SURGICAL SCAFFOLD UNK manufactured by Sofregen, Inc.
[88012382]
On 19-may-2017, sofregen became aware of an adverse event experienced by a consumer of unknown age and gender with the use of the seri surgical scaffold. The following information was provided by allergan. A physician is dissatisfied with the seri surgical scaffold relative to a patient's outcome. A case in 2015, in which the seri scaffold did not become incorporated. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013417188-2017-00015 |
| MDR Report Key | 6907360 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-27 |
| Date Mfgr Received | 2017-05-19 |
| Date Added to Maude | 2017-10-02 |
| 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 | 2017-10-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2017-10-02 |