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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 Cellulitis (1768); Seroma (2069)
Event Date 05/29/2020
Event Type  Injury  
Manufacturer Narrative
Device was not returned for analysis, as reporter indicated the device was sent for cultures. Internal investigation into lot sp200194 resulted in no remarkable findings including (b)(4) devices released to finished goods, 285 have been distributed, 11 have been reported as implanted. There has been 1 other similar complaint (mfr # 1000306051-2020-00032), and 2 unrelated complaints reported to allergan against this lot. The lot was aseptically processed, terminally sterilized, and met qc release criteria. There were no processing deviations and 1 unrelated nonconformance related to the nature of this complaint. Based on the reported information, a relationship between the event and strattice cannot be determined. If additional information is reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
Healthcare professional reported patient was implanted with strattice for breast augmentation on (b)(6) 2020. Patient had bilateral jp drains removed on (b)(6) 2020 - drains had 24-hour output of 15-20 cc each. Patient returned to the office on (b)(6) 2020 for follow up with complaints of progressive swelling in bilateral breasts. ¿dr. (b)(6)¿s exam showed tense, nontender breast with mild erythema. " "patient developed heavy seroma output around the strattice". The decision was made at that time to return to the operating room (or) to remove washout both breasts & remove strattice. " ¿fluid was evacuated in surgery on (b)(6) 2020, sent for cultures, which were negative". Strattice was unincorporated at the time of explant. The explanted strattice were also sent for cultures, the results were not reported. Patient sent to infectious disease & received iv antibiotics. Ceftriaxone 2 g iv q 24 hours & daptomycin 320 mg iv q 24 hours on (b)(6) 2020 for 2 weeks. It was reported that the seroma lead to the patient having cellulitis. Patient is "currently off of antibiotics and doing well".
 
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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
9089471470
MDR Report Key10391133
MDR Text Key208968430
Report Number1000306051-2020-00034
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
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
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Catalogue NumberCON2006
Device Lot NumberSP200194
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2020
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: 08/11/2020 Patient Sequence Number: 1
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