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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA UNIVERSAL COMPACT H.R.ASSEMBLY N/A

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INTEGRA LIFESCIENCES CORPORATION OH/USA UNIVERSAL COMPACT H.R.ASSEMBLY N/A Back to Search Results
Catalog Number UCHRA
Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 05/17/2016
Event Type  malfunction  
Event Description
Patient slipped in the uchra. There was no patient injury. Revision/medical intervention was required. Surgery delay was reported. Additional information has been requested.
 
Manufacturer Narrative
Integra has completed their internal investigation on. 08/08/2016. The investigation included: methods: -evaluation of actual device -review of device history records. -review of complaint history. Results: evaluation of device: a visual inspection of the returned uchra found no visible, physical damage to the individual assembly components or packaging. The unit went through the assessment and repair process and no visible damage or manufacturing defect was observed. Unit needs polish and clean up. Also, the scale needed repainting. Device history record reviewed for this product id lot # 775 manufactured on october 17, 2013 show no abnormalities related to the reported failure. This device passed all required inspection points with no associated mrr¿s, variances or rework. A two year look back in complaint system for this reported failure and or related to "patient slipped " for this product id shows that no additional complaints were received. No new design or manufacturing trends have been identified. This issue will be monitored. The evaluation of the returned universal compact h. R. Assembly (uchra) found no visible, physical damage. Further investigation found the unit was within specification. The failure of the uchra as related to the reported complaint was unconfirmed. The uchra was cleaned-up and polished and shipped back to the customer.
 
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Brand NameUNIVERSAL COMPACT H.R.ASSEMBLY
Type of DeviceN/A
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
Manufacturer (Section G)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
cincinnati OH 45227
Manufacturer Contact
rowena bunuan
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key5708915
MDR Text Key48134414
Report Number3004608878-2016-00139
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K944463
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUCHRA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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