MAUDE Adverse Event Report: STAPLES; STAPLE, IMPLANTABLE

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Unspecified Gastrointestinal Problem (4491); Unspecified Tissue Injury (4559)

Event Date 05/07/2009

Event Type  Injury  

Event Description

When i used bandages on the holes in my abdomen (3 holes appear) i received a rash, itching and my nurse was in shock, she turned her head.She told me it was allergic reaction and we used sterile pads with non adhesive tape.I was itching out of control.My skin was red and bleeding.My nurse stopped using bandage with adhesive because i had an allergic reaction.The second day we saw a difference.Before and after picture will be sent on the internet if needed.I may have to have a blood transfusion if blood and bleeding not resolved.My list of medications are very long.You have my permission to receive a copy.Iron pills were stopped, although i'm bleeding heavy.I have pictures that me and my nurse took.If you need them, let me know.You will see the nightmare i'm going through.Three holes appeared.The small one closed with treatment.The 2 largest ones are ongoing.I wear protection all times to prevent blood on clothes.Ask rite aid for readout sheet, thanks, rite aid phone: (b)(6).

Event Description

Additional information received from reporter on 5/3/2023 for report #mw5117200-1.Caller stated that said she does not know exactly which device is doing that, but she is suspecting it could be the staples or the mesh.

Event Description

Additional information received from reporter on 5/3/2023 for report #mw5117200.Caller stated that she is having a stabbing pain, and something is protruding and pocking inside her abdomen and she is bleeding as a result.She said she does not know exactly which device is doing that, but she is suspecting it could be the staples or the mesh.She also said her bowel collapsed.She said she has 3 holes and one is a large hole and her doctor told her it is infected.Reference report mw5117200.

Event Description

Additional information received from reporter on 01/09/2024 for report mw5117200.Reporter had a visit with her physician and she stated that her vagina has now collapsed.She states she has ongoing pain, and excessive bleeding.She now has lesions on her back that cause an itching sensation.

Event Description

Additional information received from reporter on 3/27/2024 for voluntary report number mw5117200: - caller stated since the last time of filing a report in (b)(6) 2023 her condition got worse.She woke up on (b)(6) in severe pain, discomfort and vomiting.She was transported to the hospital where she was operated on.Before the surgery a blood test was done and she was told her kidneys are dying and her bowel is obstructed.Caller stated that her bowel and vagina prolapsed.A mesh was also removed during the surgery.She was discharged home on (b)(6) 2024.Pt is recovering at home.

• Brand Name: STAPLES
• Type of Device: STAPLE, IMPLANTABLE
• MDR Report Key: 16854103
• MDR Text Key: 314510502
• Report Number: MW5117200
• Device Sequence Number: 3
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/27/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/03/2023; 05/03/2023; 01/09/2024; 03/27/2024
• Patient Sequence Number: 1
• Treatment: ALLOMAX; MARLEX MESH; STAPLES; TYCRON 3-0 VICRYL SUTURES
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native, Black Or African American