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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL JAMESON MUSCLE HOOK HOOK, OPHTHALMIC

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TELEFLEX MEDICAL JAMESON MUSCLE HOOK HOOK, OPHTHALMIC Back to Search Results
Catalog Number 421200
Device Problem Break
Event Date 05/10/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.

 
Event Description

Medwatch #mw5086768. The complaint states that during the procedure the ophthalmic muscle hook snapped and broke it the patient's left eye. An x-ray was performed in the operating room suite and it showed a metallic foreign body in the orbit. An oculoplastic surgeon/orbital specialist was consulted. Since the foreign body was surgical stainless steel it was inert in the orbit. Further exploration at this time not recommended. Follow-up appointments were scheduled with the surgeon and specialist.

 
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Brand NameJAMESON MUSCLE HOOK
Type of DeviceHOOK, OPHTHALMIC
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville , NC 27560
9194332672
MDR Report Key8749141
Report Number3011137372-2019-00224
Device Sequence Number1
Product CodeHNQ
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number421200
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/01/2019 Patient Sequence Number: 1
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