Model Number ES29202400 |
Device Problems
Mechanical Problem (1384); Mechanical Jam (2983)
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Patient Problem
No Information (3190)
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Event Date 07/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
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Event Description
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According to the available information, a pump malfunction was reported.The pump was explanted and another inflatable device was implanted.
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Manufacturer Narrative
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This follow-up mdr is created to document the conclusion of the evaluation and additional event information.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.
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Event Description
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Additional information received the patient was having sticky pump issues, and the physician wanted to exchange the pump.
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Search Alerts/Recalls
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