MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-13 for SERI SURGICAL SCAFFOLD (US) SCF10X25AGEN manufactured by Allergan (medford).
[47213755]
The device has not been returned. Therefore, no analysis or testing has been done. The event of inadequate tissue ingrowth is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
[47213756]
Healthcare professional reported seri? Surgical scaffold was placed in the left breast during mastopexy on (b)(6) 2014. Post-implantation, the device "did not absorb", and was removed on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[51515653]
Medwatch sent to fda on 08/09/2016. The device has been discarded and will not be returned. Investigation has determined that the information submitted in medwatch report 8020862-2016-00033 was duplicated in this report. All additional information regarding this device will be submitted under this report number 8020862-2016-00032.
Patient Sequence No: 1, Text Type: N, H10
[51515654]
Healthcare professional reported seri? Scaffold placed in the left breast "did not absorb". Seri? Was initially placed bilaterally to ameliorate "bottoming out" of previously placed silicone gel breast implants. No complaint was noted against the seri? Scaffold placed on the right side. The left side seri? Was removed and the event has resolved without sequelae. Left and right side silicone gel breast implants remain implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00032 |
| MDR Report Key | 5719943 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-13 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-05-22 |
| Date Mfgr Received | 2016-07-11 |
| Device Manufacturer Date | 2013-08-30 |
| Date Added to Maude | 2016-06-13 |
| 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 | 2016-06-13 |
| Catalog Number | SCF10X25AGEN |
| Lot Number | P12102201A |
| 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. Required No Informationntervention | 2016-06-13 |