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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. ESO-SPONGE OV.13MM; SPONGE, SCRUB
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B. BRAUN SURGICAL S.A. ESO-SPONGE OV.13MM; SPONGE, SCRUB Back to Search Results
Model Number 5526550
Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).Complaint states: the tube has detached form the sponge/while replacing it.After that, they have tried to get the sponge out with a so called endo -forceps.The head physician told, that it only was possible to recover the sponge bit by bit.The sponge was placed inside the patient for five days until the replacement.The sponge was placed inside a cavity, which had contact with the stomach, so that the gastric acid was able to get contact with the sponge itself.
 
Manufacturer Narrative
Reported device is not marketed in the u.S.; however, device(s) that share components and/or raw materials are.Evaluation is ongoing.
 
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Brand Name
ESO-SPONGE OV.13MM
Type of Device
SPONGE, SCRUB
Manufacturer (Section D)
B. BRAUN SURGICAL S.A.
rubi (barcelona) 0819 1
ES  08191
Manufacturer (Section G)
B. BRAUN SURGICAL SA
121 carretera de terrassa
rubi (barcelona) 0819 1
ES   08191
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key4734323
MDR Text Key5586628
Report Number2916714-2015-00353
Device Sequence Number1
Product Code GEC
Combination Product (y/n)N
PMA/PMN Number
NARRATIVE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5526550
Device Catalogue Number5526550
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2015
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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