MAUDE Adverse Event Report: ALLERGAN UNK SERI SURGICAL SCAFFOLD

Catalog Number UNK SERI SURGICAL SCAFFOLD

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Seroma (2069)

Event Date 11/18/2014

Event Type  Injury  

Event Description

Physician reported implantation of seri on (b)(6) 2014.Post-implantation, patient presented with perforation of the skin and seroma.The device was removed on or about (b)(6) 2014 where it "was not integrated in the tissue." the physician observed "multiple polyp-like fibrin plaques" on the device at explantation.The device is unavailable for analysis.

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of seroma, "perforation of the skin", and "not integrated in the tissue" are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.The physician discarded the device when it was explanted and it is no longer available for return.Therefore, allergan will not receive the device and no analysis or testing will be done.These events are being reported because medical intervention was required, although device relatedness has not been established.

• Brand Name: UNK SERI SURGICAL SCAFFOLD
• Manufacturer (Section D): ALLERGAN; medford MA
• Manufacturer (Section G): MEDFORD; 200 boston avenue; medford MA 02155
• Manufacturer Contact: krista alvarado ; 301 w. howard lane suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4360210
• MDR Text Key: 5234457
• Report Number: 3008374097-2014-00138
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2014

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?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/19/2014
• 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