MAUDE Adverse Event Report: ALLERGAN UNK SERI SURGICAL SCAFFOLD

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Fever (1858); Skin Irritation (2076); Fluid Discharge (2686)

Event Date 01/14/2014

Event Type  Injury  

Event Description

Company representative reported post-implantation with seri, patient presented with "fever, leaking fluid, skin irritation and redness." seri device was subsequently explanted.Further information has been requested from the physician, but not provided.

Manufacturer Narrative

Device availability for return is unknown, therefore, allergan may not receive it and no analysis or testing may be done.The events of drainage, fever, erythema, and irritation/inflammation are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding the event and product details has been requested.No additional information is available at this time.

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3701215
• MDR Text Key: 19802605
• Report Number: 3008374097-2014-00010
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SERI SURGICAL SCAFFOLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention