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

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.

• Brand Name: UNIVERSAL COMPACT H.R.ASSEMBLY
• Type of Device: N/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 Key: 5708915
• MDR Text Key: 48134414
• Report Number: 3004608878-2016-00139
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UCHRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1