MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. WALLACE¿ VAGINAL RING PESSARY; PESSARY, VAGINAL

Catalog Number	700/300/110
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Renal Failure (2041); No Code Available (3191)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported after use of a wallace¿ vaginal ring pessary, the patient experienced ureteral obstruction and acute post-renal failure.The adverse events were observed after a ct scan, which is when significant dilation of a ureter was confirmed on both sides.The pessary was then removed and an indwelling bladder caterer was placed.The patient's serum creatine was increased 3.2mg/dl.After this treatment, the patient excreted the maximum volume of dilute urine.The next morning, the patient's serum creatine was decreased to 0.8mg/dl.The patient then recovered after one day of observation.No permanent injury was reported.

• Brand Name: WALLACE¿ VAGINAL RING PESSARY
• Common Device Name: PESSARY, VAGINAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6678481
• Report Number: 3012307300-2017-01396
• Device Sequence Number: 13946323
• Product Code: HHW
• UDI-Device Identifier: 15019315015373
• UDI-Public: 15019315015373
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 700/300/110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 67