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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Prolapse (2475)
Event Date 12/25/2020
Event Type  Injury  
Manufacturer Narrative
Article citation: brunbjerg, mette eline et al. ¿reinforcement of the abdominal wall with acellular dermal matrix or synthetic mesh after breast reconstruction with the pedicled transverse rectus abdominis musculocutaneous flap. A prospective double-blind randomized study. ¿ journal of plastic surgery and hand surgery, 1-8. 25 dec. 2020, doi:10. 1080/2000656x. 2020. 1856673. (b)(4). The device was not returned for evaluation and the lot number remains unknown; therefore, internal investigation into the event could not be performed. 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
Article entitled "reinforcement of the abdominal wall with acellular dermal matrix or synthetic mesh after breast reconstruction with the pedicled transverse rectus abdominis musculocutaneous flap. A prospective double-blind randomized study" was reviewed: introduction: the pedicled transverse rectus abdominis musculocutaneous flap (p-tram) is a well-established option for autologous breast reconstruction (br) but donor-site morbidity is still reported. The aim of the present study was to compare donor-site morbidity after reinforcement of the abdominal wall regarding development of bulging or hernia, abdominal muscle strength, complications, and abdominal pain hypothesizing, that reinforcement with acellular dermal matrix (stratticetm) is superior to reinforcement with synthetic mesh (prolenevr ). Materials and methods: a randomized, prospective, double-blind study was conducted with 29 patients admitted for br with the p-tram flap at department of plastic surgery, auh, denmark, 2014¿2016. Allocation rate 1:1. Follow-up at 4, 12, and 24months. Results: 24months postoperatively the computerized tomography verified bulging frequency was 35. 7% in the adm group and 6. 7% in the synthetic mesh group (p¼0. 11). Two patients (14. 3%) in the adm group and no patients in the synthetic mesh group developed hernia. No significant difference between baseline and 2-year measurement of abdominal muscle strength was observed. Conclusion: the present study did not demonstrate any statistically significant differences between treatment groups regarding risk of bulging or hernia, abdominal muscle strength, complications, pain or pain related qol within two years of follow-up. Although the small sample size sets limitations for drawing wide conclusions the hypothesis that reinforcement with adm is superior to synthetic mesh cannot be confirmed. Further research into methods for decreasing donor-side morbidity related to the tram flap or other rectus abdominis muscle-based flaps is needed.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ
Manufacturer Contact
michelle burgess
1 millennium way
branchburg, NJ 
9089471470
MDR Report Key11352519
MDR Text Key241564633
Report Number1000306051-2021-00015
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
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 Received01/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/19/2021 Patient Sequence Number: 1
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