MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-07 for SERI SURGICAL SCAFFOLD (US) SCF10X25AGEN manufactured by Allergan (medford).
[54096501]
The device was discarded and will not be returned. Therefore, no analysis or testing will be done. The events of infection, seroma, and drainage 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
[54096502]
On (b)(6) 2015 the patient underwent a primary reconstruction surgery in which seri? Was placed in the inframammary fold to pectoralis major position to support concomitantly placed 410 cohesive silicone gel breast implants. Seri? Was dipped in bacitracin prior to implant and the surgical site was irrigated with same. On (b)(6) 2016, the patient reported "red bumps" and "tenderness" under the left breast. On (b)(6) 2016, the patient was prescribed doxycycline. On (b)(6) 2016, physician saw the patient and performed a "drainage" of "built up fluid. " "redness" was noted. On (b)(6) 2016 the patient was diagnosed with an infection. On (b)(6) 2016 the patient was prescribed augmentin. On the evening of (b)(6) 2016 the patient was admitted to the emergency room due to infection and pain, and on (b)(6) 2016, the breast implants and seri? Scaffold were removed in the admitting hospital. The breast implants and seri? Were all discarded. It is unknown whether any portion of the device remains implanted. The patient has since fully recovered. This medwatch represents the left side. See mfr # 8020862-2016-00042 for the right side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00041 |
| MDR Report Key | 5933313 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-07 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-08-10 |
| Device Manufacturer Date | 2015-04-30 |
| Date Added to Maude | 2016-09-07 |
| 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 | 2016-09-07 |
| Catalog Number | SCF10X25AGEN |
| Lot Number | P14121201A |
| Device Expiration Date | 2018-03-31 |
| 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 | 2016-09-07 |