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 2017-05-01 for UNK SERI SURGICAL SCAFFOLD manufactured by Allergan (medford).
[74100671]
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. " 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. Further information from the reporter regarding this event has been requested. No additional information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
[74100672]
Healthcare professional reported a patient was implanted with seri? Surgical scaffold in a revision breast reduction. After implantation, patient experienced drainage, seroma, and? Incision opened up?. Doctor removed a large piece of seri? That did not incorporate. The wound is still not healed and patient is still packing the wound on a daily basis. Side unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2017-00009 |
| MDR Report Key | 6534746 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2016-12-17 |
| Date Mfgr Received | 2017-04-05 |
| Date Added to Maude | 2017-05-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2017-05-01 |
| 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 | 2017-05-01 |