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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Anaphylactoid (2218)

Event Type  Injury  

Manufacturer Narrative

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 that a wallace ring-shaped vaginal pessary caused an allergic reaction in the patient.The patient's throat "swelled up".It was noted that due to the patient's age, surgically removing was "not a good idea".No permanent injury was reported.

• Brand Name: WALLACE¿ RING-SHAPED VAGINAL 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; CP 66 603; MX CP 66603
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6702922
• MDR Text Key: 79668268
• Report Number: 3012307300-2017-01455
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2017
• 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 Outcome(s): Other