MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-29 for SERI SURGICAL SCAFFOLD (US) SCF15X25AGEN manufactured by Allergan (medford).
[71174050]
(b)(4). The reported events are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events. The device will not be returned. Therefore, no analysis or testing can be done. Device labeling addresses the reported event 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
[71174051]
Healthcare professional reported patient had an adverse reaction to the seri? Surgical scaffold. Seri? Surgical scaffold was used due to the patient having poland syndrome and was concomitantly placed on the right side with a silicone gel breast implant. Patient experienced? Breast pain? , the "wound itself opened up on its own",? Drainage? , "some inflammation? , and "some viscous fluid in the pocket but it did not appear purulent". The seri? Surgical scaffold and breast implant were explanted and the events have resolved without sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2017-00007 |
| MDR Report Key | 6443587 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-29 |
| Date of Event | 2017-02-03 |
| Date Mfgr Received | 2017-03-03 |
| Device Manufacturer Date | 2014-08-31 |
| Date Added to Maude | 2017-03-29 |
| 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 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 | 2017-03-29 |
| Catalog Number | SCF15X25AGEN |
| Lot Number | P14071801A |
| 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 | 2017-03-29 |