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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLTENE/WHALEDENT, INC. HYGENIC; DENTAL DAM CLAMP
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COLTENE/WHALEDENT, INC. HYGENIC; DENTAL DAM CLAMP Back to Search Results
Catalog Number H09966
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, customer stated that molars clamps sets 13a and 12a were used on maxillary molar 4 and both sets fractured during use, without warning between 1st usage and 10th usage.On all occasions, clamps flossed and retrieved without incident.All clamps rusted with sodium hypochlorite use (5.25%).Additional information was provided on 08/08/2022 as follows: the clamps broke during the procedure.The first one at about 15-30 minutes into the procedure, and the second one at about one hour into the procedure.On both occasions, the dental dam came off the tooth.
 
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Brand Name
HYGENIC
Type of Device
DENTAL DAM CLAMP
Manufacturer (Section D)
COLTENE/WHALEDENT, INC.
235 ascot parkway
cuyahoga falls OH 44223
Manufacturer (Section G)
COLTENE/WHALEDENT, INC.
235 ascot parkway
cuyahoga falls OH 44223
Manufacturer Contact
tricia cregger
235 ascot parkway
cuyahoga falls, OH 44223
MDR Report Key15365990
MDR Text Key299353725
Report Number2416455-2022-00010
Device Sequence Number1
Product Code EEF
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberH09966
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/08/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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