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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA, INCSILIMED VAGINAL STENT

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SIENTRA, INC SILIMED VAGINAL STENT   Back to Search Results
Model Number 3521
Event Date 05/23/2008
Event Type  Malfunction   Patient Outcome  Other
Event Description

The pt suffered from vaginal agenesis. The vaginal stent (product number 3521-095) was inserted in the operating room during the creation of a neovaginal cavity on (b) (6) 2008. The day after the surgery, the stent fell out. The stent was inserted back in place and it fell out once again. Upon inspection, it appeared that the stent was no longer inflated to the level it was when it was placed into the vaginal canal. The stent was inflated outside of the pt's body and it stayed inflated. It was inspected and no holes were found. The stent was once again inserted in the pt and once again, it came out. Upon inspection it was noted that the stent had deflated. The pt underwent a second surgery on (b) (6), 2008 and an alternative device was used to replace the vaginal stent.

 
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Brand NameSILIMED VAGINAL STENT
Manufacturer (Section F)
SIENTRA, INC
goleta CA
Manufacturer (Section D)
SIENTRA, INC
goleta CA
Manufacturer (Section G)
SILIMED-SILICONE E INSTRUMENTAL, MEDICO-CIRURGICO
374-vigario geral
rua figueredo rocha
rio de janeiro
BRAZIL 21240660
Manufacturer Contact
joann kuhne
6500 hollister avenue
suite 120
goleta , CA 93117
(805) 562 -3500
Device Event Key1347473
MDR Report Key1069987
Event Key1028018
Report Number1651189-2008-00001
Device Sequence Number1
Product CodeKXP
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/02/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date09/30/2010
Device MODEL Number3521
Device Catalogue Number3521-095
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received05/28/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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