MAUDE Adverse Event Report: JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., MEDICAL ACTION INDUSTIRES; LAP SPONGE 18×18 W/XR RING 200/CS

Model Number	402
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lap sponge ring or blue loop are used for helping doctor to pull the lap sponge outside from the abdomen after operation.After operation, the patient will be treated with x-ray scan to check if any foreign component like ring or blue loop etc.Left inside the patient's body.Lap sponge ring contains barium sulfate, and it can be visible under x-ray, so even this ring left inside the patient's body, it can be detected under x-ray, so this problem did not result in serious injury or death.So need not remedial action for this problem.
Event or Problem Description
Lap sponge ring detached from sponge and was discovered or sponge count at which time it fell onto the floor and was retrieved by or staff.The sponge therefore was not used for procedure.The complaint lap sponge was medical action industries branded; however, the sponges were manufactured by (b)(4) province, jianerkang medical dressing co., ltd of (b)(4).Mw 5066601 was received from fda for this occurrence as well.

• Brand Name: MEDICAL ACTION INDUSTIRES
• Common Device Name: LAP SPONGE 18×18 W/XR RING 200/CS
• Manufacturer (Section D): JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO.,; zhixi town; jintan, jiangsu 21325 1; CH 213251
• MDR Report Key: 6597786
• Report Number: 9616874-2017-00002
• Device Sequence Number: 18854780
• Product Code: GDY
• UDI-Device Identifier: 10809160000106
• UDI-Public: 10809160000106
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Inspection,Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2017

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
• Operator of Device: No Information
• Device Expiration Date: 01/28/2019
• Device Model Number: 402
• Device Catalogue Number: 402
• Device Lot Number: 1601JK304A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention