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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES PERMACOL MESH, SURGICAL Back to Search Results
Model Number P151015
Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Nausea (1970); Pain (1994); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); Abdominal Distention (2601); No Code Available (3191)
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 umbilical hernia. It was reported that after implant, the patient experienced recurrence, chronic non-healing draining abdominal wound, deep subcutaneous abscess pockets with purulent fluid, drain clogged up and pocketed at this material in the subcutaneous position, whitish color of the porcine mesh, small flakes of the mesh coming off, infection, bulge in abdomen, pain, nausea, several loops of small bowel that stuck to the fascia and the previous mesh, and tight adhesions. Post-operative patient treatment included incision and drainage of abdominal wall abscess and wound debridement, placement of draining tube, recurrent incarcerated incisional hernia repair with mesh and excision of mesh.
 
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Brand NamePERMACOL
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8495189
MDR Text Key141318572
Report Number9617613-2019-00043
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2012
Device Model NumberP151015
Device Catalogue NumberP151015
Device Lot Number09B0108
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 04/09/2019 Patient Sequence Number: 1
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