MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. ESO-SPONGE OV.13 MM

Model Number 5526550

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S, however similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device resisted within the u.S are.Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).While withdrawing the sponge, the sponge ripped off while pulling.The item has been washed flushed.The residual parts of the sponge, had to be recovered with an alligator forceps.

Event Description

Additional information: initial report filed in error.The initial report indicates: reported device not marketed in the u.S., however similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medial device resisted within the u.S.Are.This statement is incorrect, a med watch report was not required.There are no similar devices or devices that share any mentioned characteristic registered in the u.S.

• Brand Name: ESO-SPONGE OV.13 MM
• Type of Device: SPONGE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona), es 08191
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona), es 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5011673
• MDR Text Key: 24246762
• Report Number: 2916714-2015-00710
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NARRATIVE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5526550
• Device Catalogue Number: 5526550
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other