MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-12-15 for SERISCAFFOLD SURGICAL SCAFFOLD (OUS) SCF10X25AEGEN manufactured by Allergan (medford).
[62524956]
Allergan has initiated an investigation into this late report. (b)(4). Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. 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 has not been returned. Therefore, no analysis or testing has been 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. " these events are being reported because medical intervention was required, although device-relatedness has not been established.
Patient Sequence No: 1, Text Type: N, H10
[62524957]
Patient representative reported implantation of seri? During right mastectomy and immediate reconstruction with permanent breast implant and seri device on (b)(6) 2014. Following surgery the surgical site began to drain. 150 ml were drained overnight. The patient fainted and fell on (b)(6) 2014. The patient was examined that day and the right breast was noted to be swollen, and the wound continued to drain 250 ml over 24 hours. The next morning it was noted there had been no output from the drain overnight and that the wound was swollen and enlarged. The doctor tried to massage the area to get the fluid to drain out. Follow-up exam on (b)(6) 2014 noted the breast was swollen, sore and red. On (b)(6) 2014, the patient presented "feeling unwell" and required hospitalization with antibiotic treatment for an infection. Ultrasound on (b)(6) 2014 showed collection of 200 ml of fluid around the implant. "foul-smelling" fluid was aspirated the next day. The patient's physician noted "spiking temperature". On (b)(6) 2014, the wound site opened and drained. The devices were removed on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[69602779]
From the review of the device history records for lot p13072401a all non-conformances were addressed and were determined to have no impact on product quality and safety. There is no evidence in the manufacturing history of lot p13072401a to suggest that a manufacturing error caused the device complaint.
Patient Sequence No: 1, Text Type: N, H10
[69602780]
Patient representative reported implantation of seri? During right mastectomy and immediate reconstruction with permanent breast implant and seri device on (b)(6) 2014. Following surgery the surgical site began to drain. The 150 ml were drained overnight. The patient fainted and fell on (b)(6) /2014. The patient was examined that day and the right breast was noted to be swollen, and the wound continued to drain 250 ml over 24 hours. The next morning it was noted there had been no output from the drain overnight and that the wound was swollen and enlarged. The doctor tried to massage the area to get the fluid to drain out. Follow-up exam on (b)(6) /2014 noted the breast was swollen, sore and red. On (b)(6) 2014, the patient presented "feeling unwell" and required hospitalization with antibiotic treatment for an infection. Ultrasound on (b)(6) 2014 showed collection of 200 ml of fluid around the implant. "foul-smelling" fluid was aspirated the next day. The patient's physician noted "spiking temperature". On (b)(6) 2014, the wound site opened and drained. The devices were removed on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00050 |
| MDR Report Key | 6179183 |
| Report Source | OTHER |
| Date Received | 2016-12-15 |
| Date of Report | 2017-03-10 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2013-08-30 |
| Date Added to Maude | 2016-12-15 |
| 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 | SERISCAFFOLD SURGICAL SCAFFOLD (OUS) |
| Generic Name | MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXF |
| Date Received | 2016-12-15 |
| Catalog Number | SCF10X25AEGEN |
| Lot Number | P13072401A |
| Device Expiration Date | 2016-07-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-12-15 |