CONVATEC INC. ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT; DEVICE, CYSTOMETRIC, HYDRAULIC,
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Model Number ABV321 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2012 |
Event Type
malfunction
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Manufacturer Narrative
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Initial emdr is being re-submitted per request of fda on 29-apr-2021.Reported to the fda on 04-nov-2015.On 17-dec-2015, the following correction was identified: the report submitted on 04-nov-2015, with the patient identifier (b)(6), had the incorrect manufacturer report number listed 1722554-2015-31259.The correct manufacturers report number should have been 1049092-2015-31259.Reported to the fda on 18-dec-2015.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).
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Event Description
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It was reported that the nurse applied abvisor to end user and once placed, noted crack in green diaphragm and leakage.The nurse removed abvisor and replaced with new abvisor.
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Search Alerts/Recalls
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