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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PERITONEALKATHETER 1200MM; HYDROCEHPHALUS MANAGEMENT
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CHRISTOPH MIETHKE GMBH & CO. KG PERITONEALKATHETER 1200MM; HYDROCEHPHALUS MANAGEMENT Back to Search Results
Model Number FV072P
Device Problem Infusion or Flow Problem (2964)
Patient Problem Hydrocephalus (3272)
Event Date 12/02/2020
Event Type  Injury  
Manufacturer Narrative
We expect the product for testing.When following information is provided a follow-up will be submitted.
 
Event Description
It was reported that there was a problem with a peritoneal catheter the pressure could not be changed with product and the cerebrospinal fluid could not be discharged, resulting in clogging.No further information available.The same patient from #mdr notification : 3004721439-2020-00257; 00258; 00259.
 
Event Description
Patient data: age: 1 year weight: 9 kg height: 70 cm gender: unknown.Implantation: (b)(6).Explantation: (b)(6).The same patient from #mdr notification : 3004721439-2020-00257; -00259; -00258 and 00269.
 
Manufacturer Narrative
Visual inspection in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damages, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: - no visible abnormalities detected.Permeability test to check if the peritoneal catheter are blocked, we have performed a permeability test on the product.The test showed that the peritoneal catheter was permeable.Internal inspection of product in order to verify whether the investigated peritoneal catheter were compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the catheter.After dismantling of the catheter, was not deposits were found.Results based on our investigation, we are not able to substantiate the claim of "blockage".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.We can exclude a defect at the time of release.The product system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
 
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Brand Name
PERITONEALKATHETER 1200MM
Type of Device
HYDROCEHPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
ulanenweg 2
potsdam, 14469
GM  14469
MDR Report Key11004099
MDR Text Key221486370
Report Number3004721439-2020-00260
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K011030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberFV072P
Device Catalogue NumberFV072P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Date Manufacturer Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age1 YR
Patient Weight9
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