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Medical Devices / Inspections and Audits

Aesculap Gets Form 483 for Untimely Reports

Jan. 3, 2017
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Aesculap Inc. was cited in a Form 483 for neglecting to file timely medical device reportable (MDR) events and establish timely corrective and preventive actions in response to complaints.

 A September inspection of Aesculap’s Hazelwood, Mont., facility discovered that the surgical instrument manufacturer had not filed about 25 medical device reportable events within 30 days of learning that one of its devices may have caused or contributed to a death or serious injury. Sixteen of the 25 late reports resulted from not entering complaints into the firm’s complaint handling system in a timely manner. — Jeff Kinney

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