MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL MESH, SURGICAL

Model Number P151015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Hematoma (1884); Unspecified Infection (1930); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Diaphoresis (2452); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced an open wound, (b)(6), recurrence, prostatic calcifications, atrophy of the right-sided rectus muscle of the anterior abdominal wall, bulging, serous discharge, seroma, pain, wound infection, dehisced surgical wound, hematoma, coughing, night sweats, adhesions, lump, abdominal pain, tenderness, hard/nodular mass, scar tissue, loss of domain, loss of integrity of anterior abdomen, gangrene on the right scrotum, and lipoma. Post-operative patient treatment included revision surgery, incision/drainage of wound, antibiotics, wound vac, excision of dehisced surgical wound, evacuation hematoma, reconstruction rlq, debridement, reconstruction by elevation and transposition of bilateral fasciocutaneous advancement flaps, hernia repair with new mesh, resection horizontally-oriented unstable scar deformity/redundant epidermis/dermis/subcutaneous tissue/fascia within the rlq of anterior abdominal wall measuring, hernia repair with components separation rectus abdominus muscle flaps based upon the inferior epigastric and superior epigastric neurovascular bundles, tissue rearrangement, hernia sac removed, transposition of the rectus abdominus muscle flap for reconstruction of fournier¿s gangrene on the right scrotum, and medication.

• Brand Name: PERMACOL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12449008
• MDR Text Key: 270803783
• Report Number: 9617613-2021-00030
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000160
• UDI-Public: 10884523000160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: P151015
• Device Catalogue Number: P151015
• Device Lot Number: 05B37-1
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/09/2021 Patient Sequence Number: 1