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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN ELASTOMERIC PUMP; ELASTOMERIC HFR

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AVANOS MEDICAL INC. UNKNOWN ELASTOMERIC PUMP; ELASTOMERIC HFR Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Tinnitus (2103); Chills (2191); Numbness (2415); Taste Disorder (4422)
Event Type  Injury  
Event Description
It was reported there was an unspecified event where during use of the pain block pro device there were reports of side effects such as fever, chills, lip numbness/tingling, ringing in ears and/or metallic taste.
 
Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6) 2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint comp(b)(4).
 
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Brand Name
UNKNOWN ELASTOMERIC PUMP
Type of Device
ELASTOMERIC HFR
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT S. DE R.L. DE C.V.
ave noruega edificio d-1b
fraccionamiento rubio
tijuana b.c. 22116
MX   22116
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key13842520
MDR Text Key287677426
Report Number2026095-2022-00018
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/22/2022
Initial Date FDA Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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