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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG H2O2 XL-MINI CONT.LID W/HANGER NON-ANOD. SCOPE CONTAINER BOTTOMS AND LIDS

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AESCULAP AG H2O2 XL-MINI CONT.LID W/HANGER NON-ANOD. SCOPE CONTAINER BOTTOMS AND LIDS Back to Search Results
Model Number MD150
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Laceration(s) (1946)
Event Date 06/29/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going.

 
Event Description

Country of complaint: usa. Cs staff member cut hand on md150, xl mini lid, on the id tag holder. Also concerned about tearing holes in wrapper if next to it. They do not use id tags.

 
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Brand NameH2O2 XL-MINI CONT.LID W/HANGER NON-ANOD.
Type of DeviceSCOPE CONTAINER BOTTOMS AND LIDS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key7728514
MDR Text Key115294885
Report Number9610612-2018-00336
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK792558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMD150
Device Catalogue NumberMD150
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/18/2018
Event Location No Information
Date Manufacturer Received06/29/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/27/2018 Patient Sequence Number: 1
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