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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2) MESH, SURGICAL

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LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2) MESH, SURGICAL Back to Search Results
Catalog Number CON2006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seroma (2069); Post Operative Wound Infection (2446)
Event Date 02/26/2018
Event Type  Injury  
Manufacturer Narrative
Our investigation of lot sp100540 includes: manufacturing review: review of information as reported, review of the device history records and complaint. History. Records associated with lot sp100540. Results of evaluation: no failure detected. Review of lot processing history and complaint history records for lot sp100540 was unremarkable. There was no processing deviation or nonconformance related to the nature of this complaint. The lot met qc criteria for release, including mechanical testing results. As of (b)(6) 2018, no similar complaint has been reported to lifecell against lot sp100540. As of (b)(6) 2018, of the (b)(4) devices released to finished goods for lot sp100540, (b)(4) devices were distributed with (b)(4) devices reported to be implanted. Evaluation conclusion: known inherent risk of device. Device not returned. Based on our internal review of the device processing history, the lot met qc criteria for product release. The event is unlikely related to strattice bps. Lot sp100540 was aseptically processed, terminally sterilized within process parameters, and met qc release criteria. No deviation was encountered in association with the reported event. No other infection complaint has been reported to lifecell against lot sp100540. [(b)(4) - follow up response recipient cultures (b)(6) 2018. Pdf].
 
Event Description
It was reported that a (b)(6) year old female patient underwent revision of right breast with strattice bps due to capsular contracture on (b)(6) 2018. On (b)(6) 2018, the patient presented with post op infection resulting in surgical and medical intervention that day. Cloudy serosanguineous fluid was found around the implant and strattice bps mesh. There were no abscesses or hematoma. Her implant was intact. The pocket was washed out, a drain was placed, the patient was treated with antibiotics, and the strattice bps mesh was explanted along with the implant. The patient has since recovered and was rescheduled for follow up procedure.
 
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Brand NameMEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471100
MDR Report Key7422467
MDR Text Key105240104
Report Number1000306051-2018-00047
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2019
Device Catalogue NumberCON2006
Device Lot NumberSP100540
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/11/2018 Patient Sequence Number: 1
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