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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05

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INTEGRA LIFESCIENCES CORP DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05 Back to Search Results
Catalog Number 90620US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Pain (1994)
Event Date 07/20/2019
Event Type  Injury  
Manufacturer Narrative
The device not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A physician reported and described that on (b)(6) 2019, the 90620us duo headlight 2 bay system ¿ us, caused pain on the top of his head where the padding of the duo headlight adjustment knob met on his head during a plastic surgery.The doctor reported that after wearing the device for one hour the pain was severe enough that he had to take the light off and that he developed a headache and felt a sore spot on his head for several hours afterwards.Attempts to refit the headlight on his head were made including using the fit guide, however, the issue did not resolve.Additional information has been requested.
 
Manufacturer Narrative
Additional information received on 17sep2019 and 09oct2019 reported that the headlight was uncomfortable, hurt the doctor¿s head and gave him a headache.The product was not returned for evaluation.Lot number/serial number not received to perform device history record review.A failure analysis and determination of root cause is not possible due to product has not been returned.The reported complaint is unconfirmed.Device identifier: (b)(4).
 
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Brand Name
DUO HEADLIGHT 2 BAY SYSTEM - US
Type of Device
PFM05
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORP
311 enterprise drive
311 enterprise drive
plainsboro NJ 08536
MDR Report Key8928806
MDR Text Key155486861
Report Number2523190-2019-00102
Device Sequence Number1
Product Code FSR
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 07/29/2019
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 Catalogue Number90620US
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/29/2019
Initial Date FDA Received08/25/2019
Supplement Dates Manufacturer Received09/17/2019
Supplement Dates FDA Received10/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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