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 Problems Ulcer (2274); Impaired Healing (2378); No Code Available (3191)

Event Date 04/25/2014

Event Type  Injury  

Event Description

Health professional reported that post implantation of seri during a breast reduction surgery, pt presented with device "palpability and skin breakdown." seri device was fully explanted.During explant surgery, physician noted "expected incorporation of seri in areas where the product was flat against tissue, but in areas where seri was "bunched up", [physician] felt it had not incorporated well and was a problem." physician considers the non-incorporation to be "related to the technique [physician] used to place seri in which the 25 cm length of the product was placed in the cephalad-caudal direction spanning the nipple-areolar complex to support the breast." physician additionally reported: "developed non-healing wounds and exposure of [seri] 6 weeks post implantation.".

Manufacturer Narrative

Further info from the reported regarding product details has been requested.No additional info is available at this time.The events of "palpability, skin breakdown, non-healing wounds, and exposure" 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 it and no analysis or testing will be done.Device labeling addresses the event of extrusion.These events are being reported because med interventions 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: karen herrera ; 71 s. los carneros rd; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3940407
• MDR Text Key: 20972358
• Report Number: 3008374097-2014-00037
• 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: Physician
• Type of Report: Initial
• Report Date: 05/21/2014

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: 05/21/2014
• Initial Date FDA Received: 06/18/2014
• 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
• Patient Age: 51 YR