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 2016-06-22 for UNK SERI SURGICAL SCAFFOLD manufactured by Allergan (medford).
[47976495]
Medwatch sent to fda on 22/06/2016. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of "skin edema", drainage, 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. The device has not been returned. Therefore, no analysis or testing has been done.
Patient Sequence No: 1, Text Type: N, H10
[47976496]
Healthcare professional reported to company representative implantation of seri surgical scaffold during unknown side breast reduction on or about (b)(6) 2015. Post-implantation and beginning on (b)(6) 2016, the patient presented with "some type of skin edema". "the patient started draining", and the scaffold was removed. While inside the pocket, physician noted "the serihad not incorporated and was floating inside the pocket. "
Patient Sequence No: 1, Text Type: D, B5
[53050864]
The events of infection and "palpable benign lesion? 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
[53050865]
Physician reported the device was placed in the left breast, and a biopsy was performed to assess a? Palpable benign lesion?. During biopsy, an? Area of infection? Was noted around the seri? And the "remaining" scaffold was removed on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00034 |
| MDR Report Key | 5742929 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-22 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-04-29 |
| Date Mfgr Received | 2016-07-28 |
| Date Added to Maude | 2016-06-22 |
| 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 | UNK SERI SURGICAL SCAFFOLD |
| Generic Name | MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXF |
| Date Received | 2016-06-22 |
| Catalog Number | UNK SERI SURGICAL SCAFFOLD |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-06-22 |