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 2016-10-20 for UNK SERI SURGICAL SCAFFOLD manufactured by Allergan (medford).
[57980354]
Device has not been returned. Therefore, no analysis or testing has been done. The event of "pin point skin breakdown" 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
[57980355]
Physician reported placement of seri surgical scaffold along with concomitant breast implant "9 months ago". During an augmentation procedure. Physician reported "pin point skin breakdown" occurring "5 weeks ago" that did not heal. Treatment plan includes "local debridement and primary closure".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00046 |
| MDR Report Key | 6044916 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-20 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2016-09-28 |
| Date Added to Maude | 2016-10-20 |
| 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 | 2016-10-20 |
| Catalog Number | UNK SERI SURGICAL SCAFFOLD |
| Lot Number | NI |
| 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. Required No Informationntervention | 2016-10-20 |