Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP COLLATAPE; DENTAL PRODUCTS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA LIFESCIENCES CORP COLLATAPE; DENTAL PRODUCTS Back to Search Results
Catalog Number 0100
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/21/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Sample was not received for evaluation.Dhr review did not identify any discrepancy during the product¿s manufacturing process which could have contributed and/or be related to the reported condition.The reported lot complied with all specifications and testing requirements.Failure analysis - retain samples from the same lot number were visually inspected; no anomaly was observed in any of the units; packaging was in good condition; sealing area was acceptable; no foreign matter was observed.Five (5) units were evaluated for thickness testing.Results: all tested units were within thickness specifications (0.01 to 0.03 in.).The complaint is considered unconfirmed, no further analysis is possible at the moment; therefore, the root cause is undetermined.
 
Event or Problem Description
A physician noticed during the surgery that the thickness of the colla tape (id 0100) was thinner than usual.No patient injury and the event did not led to surgical delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COLLATAPE
Common Device Name
DENTAL PRODUCTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORP
1000 campus drive
1000 campus drive
princeton NJ 08536
MDR Report Key10283278
Report Number1121308-2020-00008
Device Sequence Number15678690
Product Code LPG
Combination Product (Y/N)N
PMA/510(K) Number
P840062
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number0100
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2020
Initial Report FDA Received Date07/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-