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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Pain (1994); Hyperesthesia (4420)
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Event Date 01/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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A review of internal complaint files from date of incident to date of this report identified no other or similar reports for this alleged incident.No investigation possible, no contact information is available, no indication that product is available for return.Unable to confirm the product involved in the alleged incident is a breg device.
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Event Description
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On april 29, 2022, breg inc.Received a medwatch report alleging hyperesthesia on forearm and nerve compression injury on patient's thumb from being fitted postoperatively with a breg slingshot shoulder immobilizer with abduction pillow 10 days after undergoing a rotator cuff repair and biceps tenodesis procedure.Current condition of patient is unknown.
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Search Alerts/Recalls
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