FDA Adverse Event Injury Summary report: N

CONEXA

MDR report key: 2983447 · Received February 28, 2013

Report

Report Number: 1000306051-2013-00016
Event Type: Injury
Date Received: February 28, 2013
Date of Event: December 5, 2012
Report Date: February 8, 2013
Manufacturer: LIFECELL INC
Product Code: FTM
PMA / PMN Number: K080353
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

METHOD OF EVALUATION - REVIEW OF INFORMATION REPORTED TO LIFECELL. REVIEW OF DEVICE HISTORY RECORD FOR LOT T00100. QUERY OF LIFECELL COMPLAINT SYSTEM FOR OTHER COMPLAINTS REPORTED AGAINST LOT T00100. RESULTS OF EVALUATION - REVIEW OF DEVICE HISTORY RECORDS FOR CONEXA LOT T00100 (EXP. 11-2012) REVEALED NO REMARKABLE FINDINGS AND NO NONCONFORMANCES RELATED TO THE NATURE OF EVENT REPORTED. REVIEW OF DISTRIBUTION RECORDS REVEALS THAT AS OF (B)(4) 2013, (B)(4) DEVICES HAVE BEEN DISTRIBUTED. QUERY OF LIFECELL COMPLAINT SYSTEM REVEALED NO OTHER COMPLAINTS REPORTED AGAINST LOT T00100 AS OF (B)(4) 2013. CONCLUSION: NO FAILURE DETECTED AND DEVICE WITHIN SPECIFICATION BASED ON INTERNAL INVESTIGATION INCLUDING NO COMPLAINTS, NCRS ETC, EVENT IS UNLIKELY RELATED TO THE PRODUCT. PRODUCT MET QC RELEASE CRITERIA. DEVICE NOT RETURNED.

Description of Event or Problem · 1

(B)(4), LIFECELL DISTRIBUTION PARTNER, FORWARDED TO LIFECELL AN MDR FILED BY THE HOPSITAL (USER FACILITY). IT WAS REPORTED THAT ON (B)(6) 2012 PATIENT UNDERWENT ROTATOR CUFF TEAR REPAIR WITH LIFECELL DEVICE. IT WAS ALSO REPORTED THAT ON (B)(6) 2012, PATIENT RETURNED TO SURGERY FOR A SURGICAL SITE INFECTION, WHICH CONSISTED OF IRRIGATION, DEBRIDEMENT OF PREVIOUS SURGICAL SITE AND REMOVAL OF DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
87829	CONEXA	SURGICAL MESH	FTM	LIFECELL INC	050520	T00100-018

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention