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

Catalog Number 700/300/110

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Renal Failure (2041); No Code Available (3191)

Event Date 06/12/2017

Event Type  Injury  

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 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
• Type of Device: PESSARY, VAGINAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING SA DE CV; carretera miguel alemán km21.7; parque industrial monterrey; apodaca, nl CP 66 603; MX CP 66603
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6678481
• MDR Text Key: 78729622
• Report Number: 3012307300-2017-01396
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 15019315015373
• UDI-Public: 15019315015373
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700/300/110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 67