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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WATERBIRTH INTERNATIONAL HARPER BIRTH POOL

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WATERBIRTH INTERNATIONAL HARPER BIRTH POOL Back to Search Results
Event Type  No Answer Provided  
Event Description

Complainant, who wished to remain anonymous, believes this product should be classified as a powered bath, class 2 890. 5100. They do not believe the manufacturer has a 510k approval.

 
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Brand NameHARPER
Type of DeviceBIRTH POOL
Manufacturer (Section F)
WATERBIRTH INTERNATIONAL
*
Manufacturer (Section D)
WATERBIRTH INTERNATIONAL
*
Device Event Key515681
MDR Report Key526511
Event Key499766
Report NumberMW4003710
Device Sequence Number1
Product CodeILJ
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 03/12/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report?
Device Operator Invalid Data
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Event Location Unknown
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 04/28/2004 Patient Sequence Number: 1
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