MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-09-08 for SERI SURGICAL SCAFFOLD (US) SCF10X25AGEN manufactured by Allergan (medford).
[54153530]
Medwatch sent to fda on 09/08/2016. The device has been discarded and will not be returned. Therefore, no analysis or testing will be done. The events of infection, cellulitis, "a? Pinhole? On the underside of the breast through which the seri? Was visible", and inadequate tissue ingrowth are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported event of infection 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
[54153531]
Physician reported the patient underwent bilateral reconstruction revision on (b)(6) 2015 during which time style 20 silicone gel breast implants were placed. A single piece of seri? Scaffold was placed bilaterally at that time; 10 x 23 cm on the right side in the inframammary to lateral breast border position and 6 x 2 cm on the left side in a triangular shape to assist with a thin capsule following radiation therapy. Seri? Was dipped in saline prior to implantation and the surgical site was irrigated with triple antibiotic. On an unspecified date, the patient experienced an infection, was hospitalized, and given antibiotics via iv. On (b)(6) 2016, the right side seri? And concomitantly placed breast implant were removed due to infection which was later clarified to be cellulitis. Approximately 75% of the right side seri? Was unincorporated. On (b)(6) 2016, the left side seri? And concomitantly placed breast implant were also removed due to a staph infection. Physician additionally found there to be a? Pinhole? On the underside of the breast through which the seri? And breast implant were visible. 100% of the left side seri? Was unincorporated. Physician stated that 100% of the seri? Scaffold was removed from both sides. All explanted devices have been discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00043 |
| MDR Report Key | 5935419 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-09-08 |
| Date of Report | 2016-08-10 |
| Date Mfgr Received | 2016-08-10 |
| Device Manufacturer Date | 2014-02-28 |
| Date Added to Maude | 2016-09-08 |
| 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 | 2016-09-08 |
| Catalog Number | SCF10X25AGEN |
| Lot Number | P13101601A |
| Device Expiration Date | 2017-01-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-09-08 |