MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-25 for SERI SURGICAL SCAFFOLD (US) SCF10X25AGEN manufactured by Allergan (medford).
[53014664]
Medwatch sent to fda on 08/25/2016. The physician discarded the device when it was explanted and it is no longer available for return. Therefore allergan will not receive it and no analysis or testing will be done. The events of delayed healing, necrosis, and inflammation are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling addresses the reported event of inflammation as follows: adverse reactions are those typically associated with surgically. Implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.
Patient Sequence No: 1, Text Type: N, H10
[53014705]
Healthcare professional reported left side inflammation and "breakdown of tissue". And surgical site which "healed for a while, then started up again" whilst implanted with a seriscaffold and a non-allergan saline breast implant. The seri was initially placed to ameliorate a "wound that would not heal" on or about (b)(6) 2015. Following the removal of "debris" on several occasions, both the seri scaffold and the concomitantly placed breast implant were explanted on or about (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00040 |
| MDR Report Key | 5904342 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-25 |
| Date of Report | 2016-07-28 |
| Date of Event | 2015-11-01 |
| Date Mfgr Received | 2016-07-28 |
| Date Added to Maude | 2016-08-25 |
| 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 Contact | MS. SUZANNE WOJCIK |
| Manufacturer Street | 301 W HOWARD LANE SUITE 100 |
| Manufacturer City | AUSTIN TX 78753 |
| Manufacturer Country | US |
| Manufacturer Postal | 78753 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (MEDFORD) |
| Manufacturer Street | 200 BOSTON AVENUE |
| Manufacturer City | MEDFORD MA 02155 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02155 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERI SURGICAL SCAFFOLD (US) |
| Generic Name | MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXF |
| Date Received | 2016-08-25 |
| Catalog Number | SCF10X25AGEN |
| Lot Number | P14071001A |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (MEDFORD) |
| Manufacturer Address | 200 BOSTON AVENUE MEDFORD MA 02155 US 02155 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-25 |