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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MESH, SURGICAL
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BAXTER HEALTHCARE CORPORATION MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Nausea (1970); Ulceration (2116); Vomiting (2144)
Event Type  Injury  
Manufacturer Narrative
Date of event: february 2002 to december 2003. The reported product is an unknown baxter peri-strip. Literature article: s. Yu, k. Jastrow, b. Clapp, l. Kao, c. Klein, t. Scarborough, e. Wilson. ¿foreign material erosion after laparoscopic roux-en-y gastric bypass: findings and treatment¿. Surg endosc (2007) 21: 1216¿1220; doi: 10. 1007/s00464-007-9328-3. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported 153 patients underwent a two-year study in which peri-strips were used with laparoscopic roux-en-y gastric bypass. Six patients experienced post-operative events with incidence of foreign material erosion into the gastric pouch. One patient experienced a gastro-jejunal anastomotic leak and was ¿treated conservatively¿. Three patients experienced strictures, four patients experienced marginal ulcerations, 13 patients experienced nausea, 12 patients experienced vomiting, three patients experienced melena, five patients experienced dysphagia and 15 patients experienced abdominal pain. Treatment for the events was not reported. The study reported the ¿patient outcomes were determined by resolution of symptoms, improvement of symptoms, or no effect or worsening of symptoms at follow-up¿ (no further details). No additional information is available.
 
Manufacturer Narrative
Additional information: the device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameNI
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
SYNOVIS SURGICAL INNOVATIONS
2575 university ave w
saint paul MN 55114
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9888535
MDR Text Key185225152
Report Number1416980-2020-01775
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2020
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 Unkown

Patient Treatment Data
Date Received: 03/27/2020 Patient Sequence Number: 1
Treatment
NON-BAXTER SILK SUTURE
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