MAUDE Adverse Event Report: SLING

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Scarring (2061)

Event Date 05/26/2015

Event Type  Injury  

Event Description

I had fop surgery on (b)(6) 2014 and was unable to have sex with my husband after surgery.I then had an incident where i was getting off the toilet and i had a surge of blood from my vagina (was not menstrual related because i had a total hysterectomy in 2006).I had a surge of gushing deep red blood from my vagina.I followed up with the surgeon only to find that the mesh that was inserted vaginally had poled through.I also had a sling that was placed too tightly and needs to be loosened also.I have significant scarring that needs to be removed.I am currently waiting on my schedule for my surgery to have these 3 issues corrected.

• Brand Name: SLING
• Type of Device: SLING
• MDR Report Key: 4838191
• MDR Text Key: 5904690
• Report Number: MW5043031
• Device Sequence Number: 2
• Product Code: PAH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/05/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2015
• Patient Sequence Number: 1
• Treatment: LAC-HYDRIN; LYRICA; ESTRACE; NORVASC; ALDACTONE; FISH OIL; OTC MEDS: OSCAL; PRAZOSIN; INVEGA; CEROVITE ADVANCED FORMULA; ELOCON; AMITIZA; PROAIR HFA; DOC-Q-LACE; ADVAIR; PREVACID; LYNOX; ADDERALL; CYMBALTA; KLONOPIN; LEXAPRO; DITROPAN; NUVIGIL; KLOR-CON; RX MEDS: ZOVIRAX; FEROCON; FLONASE; LASIX; XYZAL
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 141