MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-07-02 for SILIMED VAGINAL STENT 3521 3521-095 manufactured by Sientra, Inc.
[891329]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651189-2008-00001 |
| MDR Report Key | 1069987 |
| Report Source | 05 |
| Date Received | 2008-07-02 |
| Date of Report | 2008-06-02 |
| Date of Event | 2008-05-23 |
| Date Mfgr Received | 2008-05-28 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2010-04-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOANN KUHNE |
| Manufacturer Street | 6500 HOLLISTER AVENUE SUITE 120 |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055623500 |
| Manufacturer G1 | SILIMED-SILICONE E INSTRUMENTAL, MEDICO-CIRURGICO |
| Manufacturer Street | 374-VIGARIO GERAL RUA FIGUEREDO ROCHA |
| Manufacturer City | RIO DE JANEIRO 21240660 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 21240660 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILIMED VAGINAL STENT |
| Product Code | KXP |
| Date Received | 2008-07-02 |
| Model Number | 3521 |
| Catalog Number | 3521-095 |
| Device Expiration Date | 2010-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIENTRA, INC |
| Manufacturer Address | GOLETA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-02 |