Model Number M0068402410 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a polyform synthetic mesh was used during a tension-free vaginal mesh (tvm) procedure performed on (b)(6) 2017.According to the complainant, during unpacking, about 5 mm of the mesh was found to be sealed at the bottom part of the sterilization pouch.That part was cut along with the pattern and the rest of the mesh was implanted.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Analysis revealed that the returned package shows evidence that the mesh was caught partway in the bottom seam of the pouch.The seal of the package was compromised but not breached.The mesh was not returned.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot. since the condition of the returned device confirms that the seal was compromised, the assigned complaint investigation conclusion code for this event is supplier manufacturing execution error.A suppliers manufacturing process was not executed as validated.There is an investigation in place to address this issue.
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Event Description
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It was reported to boston scientific corporation that a polyform synthetic mesh was used during a tension-free vaginal mesh (tvm) procedure performed on (b)(6) 2017.According to the complainant, during unpacking, about 5 mm of the mesh was found to be sealed at the bottom part of the sterilization pouch.That part was cut along with the pattern and the rest of the mesh was implanted.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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