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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994); Uterine Perforation (2121); Injury (2348); Disability (2371); Weight Changes (2607); No Code Available (3191)
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Event Date 03/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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The exact age of the patient is unknown.
However, it was reported that the patient was over 18 years.
Date of event: no event date was reported; however, it was reported that the device was implanted in (b)(6) 2018.
Therefore, date of event was approximated to (b)(6) 2018.
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.
(b)(4).
The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.
If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a boston scientific device was implanted into the patient during a procedure performed in (b)(6) 2018 to treat incontinence.
As per media post, after the implantation, the patient suffered from pain and there was an absolute tightness as if there was a clamp inside her intestines.
The patient had been bleeding for months and had to wear two diapers a day.
She was in pain when attempted to have sex.
A scan in (b)(6) revealed that the mesh had cut open her uterus and there was a massive cyst inside that did not exist before the operation.
Subsequently, the patient had the mesh removed in march last year; however, the pain still continued.
The patient claimed that the pain was so bad that she could not leave her bed and go for a run, and for that reason, she gained weight.
Boston scientific has been unable to obtain additional information regarding the event to date.
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Search Alerts/Recalls
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