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

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.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• Type of Device: MESH, 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 Key: 7422467
• Report Number: 1000306051-2018-00047
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: 00818410010270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082176
• Number of Events Reported: 1
• 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 Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CON2006
• Device Lot Number: SP100540
• 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 Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 49 YR
• Patient Outcome(s): Required Intervention