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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 P152030
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Hernia (2240); Injury (2348); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 a hernia.It was reported that after the implant, the patient experienced non-healing wound and sinus tract due to failure of the mesh, the mesh was poorly incorporated and infected.Post-operative patient treatment included mesh removal surgery.
 
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Brand Name
PERMACOL
Type of Device
MESH, 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 Key10384364
MDR Text Key202223153
Report Number9617613-2020-00069
Device Sequence Number1
Product Code FTM
UDI-Device Identifier10884523000207
UDI-Public10884523000207
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
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP152030
Device Catalogue NumberP152030
Device Lot Number07B113
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/22/2020
Initial Date FDA Received08/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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